5202 Presidents Court, Suite 220
Frederick, MD 21703
Phone: (240) 575-7499
Fax: (240) 454-9449
A2LA boasts over 35 years of experience in the quality assurance industry and offers unique accreditation options for clinical laboratories. Organizations may choose the Platinum Choice Clinical Accreditation Program, which combines CLIA requirements and ISO 15189:2012 in a single assessment. A2LA's Platinum Choice program is the only one in the world that offers domestically-recognized accreditation to CLIA requirements as well as internationally-recognized accreditation to ISO 15189:2012. Options for CLIA or ISO 15189 accreditation individually are also available.
A2LA has formed a partnership with AABB to offer a combined accreditation program for clinical laboratories, blood banks, and transfusion services. This accreditation program combines three assessment criteria into one assessment: AABB accreditation requirements, ISO 15189:2012 accreditation requirements and the clinical laboratory accreditation program (CLIA) requirements.
11400 Tomahawk Creek Parkway
Leawood, KS 66211-2672
Toll Free: (800) 274-7911
AAFP Proficiency Testing is a full-service program that helps POLs, clinics, and hospitals maintain laboratory excellence and regulatory compliance. AAFP-PT offers a variety of flexible, customizable modules and other educational products, including the POL Microscopy Atlas. Superior technical assistance and customer service provided. Participants can earn 12 CME credits.
10700 West Higgins Rd. Suite 150
Rosemont, IL 60018
Fax: (847) 823-0458
American Medical Technologists (AMT) is the nationally and internationally recognized certification agency for allied health professionals, including Medical Technologists, Medical Laboratory Technicians, Phlebotomists, Laboratory Assistants, Medical Assistants, and Allied Health Instructors. A mission-driven nonprofit for more than 75 years, AMT is also a membership association, providing continuing education and other support services to 75,000 members. AMT certification translates into staff that are trained to meet the highest professional standards and committed to ongoing recertification to ensure their capabilities remain current, relevant and practical. AMT is accredited by the National Commission for Certifying Agencies (NCCA) for all its competency-based examinations.
AMERICAN PROFICIENCY INSTITUTE
1159 Business Park Dr.
Traverse City, Ml 49686
Toll Free: (800) 333-0958 Ext. 3013
American Proficiency Institute (API) offers high quality proficiency testing for 20,000 hospital, clinic, and physician office laboratories. API's latest feature called DataDirect allows laboratories to use their laboratory information system (LIS) or middleware to transmit PT results directly to API, a process that revolutionizes external quality control for clinical laboratories! DataDirect is FREE, easy to use, and eliminates PT failures due to clerical errors! A DataDirect Specialist is available to help you implement this feature from start to finish. API is accepted by CAP, TJC, CMS, COLA and state regulatory agencies. Visit www.api-pt.com or contact us at firstname.lastname@example.org.
445 Medical Center Blvd
Webster, TX 77598
Based in south Houston, Ansh Labs is a leading developer and manufacturer of immunoassay reagent test kits used to advance target discovery, therapeutic development, biomedical research, and clinical diagnostics.
We serve life science researchers, physician researchers, hospitals, commercial laboratories, and public health agencies to assist with the research, diagnosis, treatment, and management of diseases. The products we develop make it possible to conduct novel research in Reproductive Function, Pregnancy, Growth Disorders, Neuronal Disorders, Atherosclerotic Cardiovascular Disease, and Oncology.
Ansh Labs has recently introduced a wide range of Growth Factor and species-specific assays. Glucagon Regulation assays such as Glucagon, GLP-1, and GLP-2 will be introduced soon to complement our Oxyntomodulin assay.
ARLINGTON SCIENTIFIC INC
1840 North Technology Drive
Springville, UT 84663
Toll Free: (800) 654-0146
Arlington Scientific, Inc. (ASI) is an award-winning FDA registered and CE marked manufacturer and distributor of in vitro diagnostic test kits, RPR diagnostic analyzers, EIA/ELISA test kits and analyzers, donor lounges for blood collection, apheresis, and oncology, bulk reagents and serum sets, non-invasive multi-allergen test panels, and disposable mucosal collection devices. ASI's product lines include:
* Serology test kits
* Automated RPR analyzer
* Semi-automated RPR analyzer
* Donor lounges for Blood collection, aphaeresis and oncology
* EIA/ELISA test kits
* EIA/ELISA analyzer
* Bulk reagents and serum sets
* IVT Allergy panels
* Nasal mucosal collection device
BD DIAGNOSTIC SYSTEMS
7 Loveton Circle
Sparks, MD 21152
Toll Free: (800) 638-8663
The Food and Drug Administration (FDA) has reclassified antigen based rapid influenza virus antigen detection systems (RIDTs), intended to detect influenza virus directly from clinical specimens from Class I devices into Class II devices subject to special controls., effective Feb. 13, 2017.
Prompting these changes was the inadequate performance of some point-of-care flu tests available during the 2009 flu pandemic, which raised concerns regarding the accuracy of detecting influenza inpatients. With the new FDA requirements', rapid flu tests, which are used by health care providers and laboratory personnel, must now attain a higher level of performance.
In recognizing the need to improve diagnostics, BD developed and launched the BD Veritor System for Rapid Detection of Flu A+B. This was the first Clinical Laboratory Improvement Amendments (CLIA)waived flu test that provides objective results on an easy-to-read digital display. The now Class II BD Veritor System Flu A+B test became available in 2011, and is the same test used on the new BD Veritor Plus System, a next generation wireless rapid diagnostic system for detection of influenza A and B, respiratory syncytial virus (RSV) and group A strep.
1. More information about the FDA reclassification and the BD Veritor Plus System are available at http://www.bd.com/ds/VeritorSystem.com or through BD Technical Service at 800.638.8663.
6730 Mesa Ridge Rd
San Diego, CA92121
Toll Free: (800) 633-4484
Freelite[R] assays, for the quantitation of free light chains in serum, are now recommended in the National Comprehensive Cancer Network (NCCN Guidelines[R]) for use in the initial diagnostic workup of multiple myeloma and related disorders, and by the International Myeloma Working Group for the screening, diagnosis and monitoring of multiple myeloma. Nephelometric and turbidimetric assays available on multiple platforms.
HUMAN IgG AND IgA SUBCLASS KITS
* Nephelometric and turbidimetric kits
OPTILITE[R] SPECIAL PROTEIN ANALYZER
* The newest innovation in special protein testing.
* Automatic antigen excess check
* Automated redilution
* Continuous sample loading/unloading
* Unrestricted access to samples, reagents, and cuvettes
* Automatic barcoded identification and full LIS connectivity
* Automatic lot number recognition and full traceability
Optilite assays currently include: Freelite[R] serum free light chain assays, IgG subclasses (lgG1-lgG4), IgG, Low Level IgG (CSF/urine) IgA, IgA Subclasses (lgA1-lgA2), IgM, IgD,' Acid Glycoprotein, Albumin, Low Level Albumin (CSF/urine), Antistreptolysin O, Beta-2Microglobulin, Ceruloplasmin, CH50, Cystatin C, C3c, C4, CI inactivator, Haptoglobin, Hevylite IgA Kappa, Hevylite IgA Lambda, Hevylite IgM Kappa, Hevylite IgM Lambda, Apo A1, Alpha-2-Macroglobulin, Prealbumin, Transferrin
SPAplus AUTOMATED ANALYZER FOR SERUM/ PLASMA PROTEIN ANALYSIS
* Automatic antigen excess check
* Automated rerun and autodilution capability
* Air mixing system
* Dual compartment reaction cuvettes
* Hot water wash
* Bi-directional interface
Please contact us for more details and menu for SPAplus.
RADIAL IMMUNODIFFUSION KITS
* IgG subclasses, IgA and IgA subclasses, IgD, B-2-M, CRP, Kappa, Lambda
* Transferrin, Haptoglobin, Alpha-1 -antit rypsin, Antithrombin III, Albumin, and Fibronectin
* Plasminogen, Fibrinogen, ATIII and Protein C
COMPLEMENT COMPONENT RID KITS
* CI inactivator, Clq, C3, C4, C5, CH50, Human Complement Functional Assays (Total and Alternative)
COMPLEMENT PATHWAY EIA METHOD
* CH50 Classical Complement Pathway
QUALITY ASSURANCE SCHEMA
* For Total Immunoglobulins (IgG, M, A), IgG and IgA subclasses, Paraproteins and Functional Immunoglobulins
4040 Pike Lane
Concord, CA 94520
Toll Free: (800) 799-9499
Phone: (925) 603-8000
Fax: (925) 603-8080
Biocare Medical provides a full line of IHC and molecular pathology products for cancer and infectious disease diagnosis. Biocare's portfolio includes novel and established primary antibodies for many tissue types. Our automated IHC Instrumentation, including the ONCORE and IntelliPATH FLX[R], increase throughput and provide intuitive tools. Innovations like our RISH[TM] and FISH products make ISH accessible to every laboratory. Stable and vivid IHC chromogens are available in brown, black, red, green, and blue. MACH[TM] detection polymers provide sensitivity and low background for IHC. Biocare has received multiple awards for product quality, service and support.
BIOFIRE DIAGNOSTICS, INC.
515 Colorow Drive
Salt Lake City, UT 84108
Toll Free: (800) 735-6544
BioFIre Diagnostics, Inc. manufactures and distributes the user-friendly FilmArray[R] System to hospital-based clinical laboratories across the U.S. and EU. BioFire currently offers the FilmArray Respiratory (RP) Panel, the Blood Culture Identification (BCID) Panel, the Gastrointestinal (GI) Panel and the Meningitis/ Encephalitis Panel which are FDA-cleared and CE IVD marked. The FilmArray System Is a significant advancement In user-friendliness and multiplex infectious disease testing capability for hospital clinical labs. Requiring only two minutes of hands-on time, the FilmArray System has about a 1-hour turnaround time, and each panel simultaneously tests for 20+ pathogens. BioFire continues to broaden its FilmArray test menu, and is currently developing a Lower Respiratory Panel. For further information, please visit www.biofiredx.com.
4000 Alfred Nobel Dr.
Hercules, CA 94547
Toll Free: (800) 224-6723
For over 60 years, Bio-Rad has played a leading role in the advancement of scientific discovery and healthcare by offering a broad range of products for the life science research and clinical diagnostics markets.
Quality Control: Bio-Rad leads the way for clinical laboratories with a portfolio of independent quality controls and data management software solutions to facilitate effective quality testing, analysis and compliance for hundreds of the most widely used diagnostic instruments. Our comprehensive menu of quality control products span analytes for immunoassay, TDM, chemistry, cardiac assessment, immunology, hematology, diabetes, molecular infectious disease, serological infectious disease and more. Additional Products & Services Provided:
* Blood Bank Testing
* Clinical Microbiology
* Diabetes and Hemoglobinopathy Testing
* HIV Testing
* Automation Platforms: BioPlex[R] 2200 System, EVOLIS[TM] microplate system.
* Infectious Disease and Autoimmune Assays
575 N. Patterson Avenue, Suite 430
Winston-Salem , NC 27101
Carolina Liquid Chemistries (CLC)--Upgrading a chemistry analyzer to new and faster technology can reduce overtime, service expense and reagent cost. CLC offers a wide range of new FDA Cleared instruments, over 80 different reagents, and service contract options accommodating all sizes of clinical laboratories and budgets. CLC offers the bench top CLC480/Biolis24i, the mid-size CLC800 and the CLC1600. CLC offers larger laboratories the new ultra-high speed CLC6410 Modular. Trade-ins on select instruments offered. CLC sells bar-coded reagents for use on Olympus AU instruments and affordable service contracts. CLC is Veteran owned, FDA regulated, and ISO Certified.
PO Box 529
Queen Creek, AZ 85142
Toll Free: (800) 570-0474
Phone: (480) 888-9447 Ext. 102
Fax: (480) 888-9446
Clinical Software Solutions has been in the business of providing software products and services for healthcare facilities since 1987. CLINI Laboratory & CLINI QC are affordable information management solutions for any size or type of lab. Intuitive screens with color coded fields help users accomplish their daily tasks with ease and efficiency. Industry standard SQL server technology assures that your information Is secure but accessible where and when you need it. HL7 interfaces and Web Portal reporting increase productivity and efficiency. We understand the laboratory environment and that's why we provide healthcare software that is robust and easy to use.
COLLEGE OF AMERICAN
325 Waukegan Rd
Northfield, IL 60093-2750
Toll Free: (800) 323-4040
Phone: (847) 832-7000
The College of American Pathologists is the global leader in laboratory improvement programs, including accreditation, proficiency testing/external quality assurance (EQA), and continuing education programs, all of which provide laboratories with a comprehensive view of their quality process with insight, knowledge, and peer-based educational coaching. Supported by the scientific expertise and commitment of the world's largest board-certified pathologist organization, the CAP partnership fosters collaboration and builds confidence that CAP-accredited laboratories deliver the most reliable test results to ensure accurate patient diagnoses. The CAP's Laboratory Improvement Programs, initiated more than 65 years ago, currently have customers in more than 100 countries, accrediting nearly 8,000 laboratories and providing proficiency testing to more than 20,000 laboratories worldwide. The CAP's 650+ proficiency testing/EQA programs provide the greatest range of assessment options from routine testing to testing using the most complex, cutting-edge emerging technologies.
DRG INTERNATIONAL, INC.
841 Mountain Avenue
Springfield, NJ 07081
Phone: (973) 564-7555
Fax: (973) 564-7556
DRG International, Inc., founded in 1970 in the USA, is a global innovator of high-quality medical diagnostics and equipment, providing the medical and research community with cutting edge, effective tools to build a healthier future. NEW ELISAS:
--Hepcidin-25 bioactive HS (High-Sensitive) (EIA5782)
--Salivary Hormone (Optimized ELISAS)
--Active Renin (EIA5125) 25-OH Vitamin D (EIA5396)
--FULLY AUTOMATED IMMUNOASSAY & CLINICAL CHEMISTRY ANALYZER
Please visit www.drg-international.com for details!
10 Avco Rd
Haverhill, MA 01835
Toll Free: (800) 739-9067
Fax: (978) 374-4885
Hatfield Laboratory Furniture and Laboratory Tables offer a modular design that allows you to configure your laboratory to meet your requirement. Traditional steel casework, islands or hanging cabinet we offer it all. Featuring sound deadening doors and drawers, stainless steel pulls and hinges our drawers offer 90 percent extension slides with 150 pounds capacity. Cabinets are offered in three heights, sitting, mid-height and standing. All cabinets feature leveling glides, removable rear cabinet panels allows access to utilities. Hatfield offers 10 standard powder coat paint color choices for the cabinets. We offer multiple work surface choices. We also offer economical laboratory tables with hanging cabinets to offering a truly modular ergonomic design.
11150 Sunset Hills Road, Suite 302
Reston, VA 20190
Toll Free: (888) 41 1-2851
Phone: (703) 435-6700
Committed to healthcare workers' safety, ITL specializes in design, manufacturing and marketing of safety biological sample collection and transfer devices and medical procedure kits. ITL's line of microbiology safety ancillaries include products for performing subculture processes, such as the Safety Subculture Unit, for needle-less blood culture bottle sampling. ITL's general laboratory and clinical safety ancillaries include a range of SampLok[R] safety tube holders and adapters for blood sample collection, specialized Needle Guards for blood donor and dialysis patient needle safety, and integrated safety systems used extensively for whole blood, plasma collections and patient phlebotomy procedures.
170 South Seneca Springs Way,
Star, ID 83669
Toll Free: (800) 457-6687
Phone: (208) 377-4800
Fax: (208) 377-4900
For over 30 years, KRONUS[R] has provided specialized immunoassay test kits to medical professionals at the world's most respected laboratory facilities. Please contact us directly with any questions, requests or comments that you may have. We welcome the opportunity to learn how KRONUS can be of assistance in meeting your laboratory's immunoassay test kit needs.
NEUROIMMUNOLOGY AQUAPORIN-4 AUTOANTIBODY (AQP4Ab)
* ELISA Kit, 96 Wells
ACETYLCHOLINE RECEPTOR AUTOANTIBODY (AChRAb)--BINDING AND BLOCKING
* Radioimmunoassay Kits, 25, 50 and 100 Tubes
VOLTAGE-GATED CALCIUM CHANNEL AUTOANTIBODY (VGCCAb)
* Radioimmunoassay Kits, 12 and 24 Tubes
ISLET CELL AUTOIMMUNITY GLUTAMIC ACID DECARBOXYLASE AUTOANTIBODY (GADAb)
* ELISA Kit, 96 Wells
ZINC TRANSPORTER 8 AUTOANTIBODY (ZnT8Ab)
* ELISA Kit, 96 Wells
IA-2 AUTOANTIBODY (IA-2Ab)
* Radioimmunoassay Kit, 100 Tubes INSULIN AUTOANTIBODY (IAA)
* Radioimmunoassay Kit, 100 Tubes
THYROGLOBULIN ANTIBODY (TgAb)
* Radioimmunoassay Kit, 100 Tubes THYROID PEROXIDASE AUTOANTIBODY (TPOAb)
* Radioimmunoassay Kit, 100 Tubes TSH RECEPTOR ANTIBODY (TRAb)
* ELISA Kit, 96 Wells
* Coated-Tube (CT) Radioimmunoassay Kits, 60 and 120 Tubes
* Radioimmunoassay Kits, 60 and 120 Tubes
ADRENAL AUTOIMMUNITY STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb)
* Radioimmunoassay Kits, 50 and 100 Tubes
FOR RESEARCH USE ONLY
3 SCREEN ISLET CELL (GAD/IA-2/ZnT8) AUTOANTIBODY SCREEN
* ELISA Kit, 96 Wells[dagger]
21-HYDROXYLASE ANTIBODY (21-OHAb)
* ELISA Kit, 96 Wells[dagger]
AQUAPORIN-4 AUTOANTIBODY (AQP4Ab)
* I FA Kit, 100 Fields[dagger]
VOLTAGE-GATED POTASSIUM CHANNEL AUTOANTIBODY (VGKCAb)
* Radioimmunoassay Kit, 25 Tubes[dagger]
TITIN ANTIBODY (TITINAb)
* ELISA Kit, 48 Wells[dagger]
ACETYLCHOLINE RECEPTOR ANTIBODY (AChRAb)--BINDING
* ELISA Kit, 96 Wells[dagger]
IA-2 ANTIBODY (IA-2Ab)
* ELISA kit, 96 Wells[dagger]
GAD/IA-2 ANTIBODY SCREEN
* ELISA kit, 96 Wells[dagger]
[dagger] For Research Use Only. Not For Use in Diagnostic Procedures.
5449 Research Drive
Canton, MI 48188
Toll Free: (800) 445-9853
Phone: (734) 487-8300
MedTest provides tailored clinical laboratory solutions addressing the unique challenges faced by laboratorians around the world - improve quality while reducing costs. The portfolio offers instrumentation and reagents for chemistry, hematology, and liquid chromatography/ mass spectrometry (LC/MS) labs. The extensive menu includes chemistry and drugs of abuse screening and confirmatory reagents suitable for use on our instruments or, as open-channel reagents. Our solutions span the continuum from simple labs up to highly complex labs. MedTest prides itself on delivering a superior customer experience for our Instrument Ensembles: Sales Consulting, Installation, Customer Training, Technical Support and On-Site Service.
8463 154th Ave. NE
Redmond, WA 98052
Toll Free: (855) 895-9197
Micronics, Inc. develops innovative products for near patient, point of care infectious disease molecular tests. The PanNAT[R] System is a small, fully automated easy-to-use Instrument that requires minimal hands on- providing sample to results in approximately 1 hour. All assay steps including extraction/purification, PCR and detection are performed automatically. The instrument features an intuitive on board GUI, battery backup, Wi-Fi and network/US/ HIS interface capability. All test reagents are incorporated to the PanNAT Test Cartridge which is a closed system, room temperature unit dose device. The ABORhCard[R] is a credit card sized microfluidic device that provides simultaneous detection of ABO and Rh in approximately 2 minutes for educational and informational use.
4705 Decatur Blvd.
Indianapolis, IN 46241
Toll Free: (866) 647-2847
MiraVista Diagnostics offers more than 30 years of experience providing superior fungal diagnostic testing services. We are committed to providing accurate, high-quality testing, to aid in the diagnosis and treatment of serious fungal infections.
Services offered by MiraVista Diagnostics:
MVista Antigen Detection: Histoplasma, Coccidioides, and Blastomyces Quantitative EIA Other Antigen Detection: Aspergillus Galactomannan, B-D Glucan Antibody Detection: MVista Histoplasma IgG IgM, MVista Coccidioides IgG IgM, Blastomyces, and Aspergillus
MP BIOMEDICALS, LLC
3 Hutton Centre Drive
Santa Ana, CA 92707
Phone: (800) 633-1352 Ext. 2077
MP Biomedicals is a leading global supplier for Diagnostics, Life Sciences, and Fine Chemical products, serving you for over 40 years. Alongside our vast laboratory reagent and fine chemical portfolio, we supply diagnostic assays for Endocrine Hormones, Biogenic Amines, Tumor Markers, Cardiac Markers, Newborn Screening, and Blood Donor Testing. You can count on MP Biomedicals for competitive pricing, superior quality, and proven performance for all of your laboratory needs. Contact us today to learn more.
25 Birch Street Building B
Milford, MA 01757
Toll Free: (800) 345-1514
Since 1976, Psyche Systems has delivered products that help laboratories of all sizes run more efficiently and cost-effectively. Psyche's e.Outreach, EMR Internet Interface, MicroPath, WindoPath AP system, WPTox toxicology LIS, and NucleoLIS molecular information management system deliver a completely integrated solution for all areas and types of laboratories. Psyche's products are fully integrated or stand-alone and support full automation, integration with instruments, clinical and back-office systems, Outreach and Meaningful Use initiatives.
31 School St
Guilford, ME 04443
Toll Free: (800) 321-2313
Puritan Medical Products, founded in 1919, is an American company known worldwide as the most trusted manufacturer of swabs and other single-use products for the healthcare, forensic, controlled environments, food safety, and drug manufacturing industries. Products include patented HydraFlock[R] and PurFlock Ultra[R] flocked swabs, media transport systems, environmental surface sampling kits, and a brand new line of liquid based media.
RAMCO LABORATORIES INC.
4100 Greenbriar Dr, Ste 200
Stafford, TX 77477
Toll Free: (800) 231-6238
CANDIDA ANTIGEN (CAND-TEC)
A latex agglutination assay used in the diagnosis of systemic candidiasis through the detection of candida antigen in human serum.
FERRITIN--EIA (SPECTRO FERRITIN)
An enzyme immunoassay for quantifying the level of serum ferritin, in microplate format.
PREGNANCY TESTS (QUIK-TRAK)
Cassette tests for the rapid qualitative determination of hCG in serum and/or urine.
TRANSFERRIN RECEPTOR (TfR)
An EIA for quantifying the level of transferrin receptor in human serum or plasma, in microplate format.
von WILLEBRAND FACTOR (VFE)
An EIA for the quantification of human von Willebrand factor antigen in plasma, in microplate format.
P.O. Box 468
Newton, NC 28658
Toll Free: (800) 257-5101
Phone: (828) 465-4000
Fax: (828) 465-4003
* Modular automation solutions with options for bulk loading, identification, sorting, decapping, aliquoting, recapping, and transfer to track system
* General labware
* Innovative blood and specimen collection
* Transfusion equipment
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|Publication:||Medical Laboratory Observer|
|Date:||Aug 1, 2017|
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