Products/Services for CLIA Waived
Product News for CLIA Waived
Traceable® Conductivity/TDS/Salinity Meters Traceable® Conductivity/TDS/Salinity Meters Complete Description. Three units provide for conductivity, conductivity/total dissolved solids, and salinity. Pens fulfill requirements for CAP, ASTM, NCCLS, CLSI, ACS, CLIA, AOAC, EPA, APHA, AWWA, WEF, USGS, USP, ISO, and Federal/State regulations. Easy to use and waterproof. Simply turn on, insert, and simultaneously read result and temperature. Easiest unit ever designed for routine analysis and quality control. Elimination of operator technique... (read more)Browse Conductivity and Resistivity Meters Datasheets for Control Company
Traceable® Conductivity Calibration Standards conductivity (microsiemens/micromhos), resistivity (ohms), and dissolved solids (parts per million). Methods supported. This certified reference material meets test requirements for Federal, State, and local agencies, CAP, CLSI, ACS, and CLIA. Traceable® Certified Reference Material complies with and is essential for use in these official methods: AOAC 973.40, EPA 120.1, Standard Method 2510 (APHA AWWA WEF), ISO 7888, DIN 38404, ASTM D1125, USGS I-1780, USP 24 NF19, USP 645, OIML R56, IUPAC... (read more)
Traceable® Humidity/Temperature/ Dew Point Meter and Technology). Clean room and food applications. Fulfills federal CLIA requirements and is ideal for hoods, clean rooms, food storage, process control, incubators, desiccators, drug manufacturing, environmental chambers, corrosion analysis, and inside/outside air monitoring. Four-digit LCD display can be read from 10 feet. Rugged handheld unit is designed for years of service. Hi/Lo memories, programmable alarms, and data output. Memory recalls both highest and lowest readings in dew point... (read more)Browse Humidity Measurement Instruments Datasheets for Control Company
...to compete with the labs, POC tests need to be inexpensive and user-friendly, and they must match the performance of lab tests. Ease of use is also critical for obtaining CLIA-waived status, which is an FDA approval that allows a test to be conducted by nonexpert users. This waiver means...
...and judgment. The regulations describe three different categories for tests: high complexity, moderate complexity (including provider-performed microscopy), and waived. Waived tests would require the least amount of government oversight. The 1992 regulation (42 CFR sec. 493.15) indicated that waived...
...complexity, or waived). To date, CDC has categorized approximately 26,000 test systems. This complexity assignment is of central importance to the CLIA program because it determines which laboratories may purchase and use a particular test. Laboratories certified under the CLIA inspection program...
...labs are required to have a current and valid CLIA certificate to test human specimens. The requirements for quality control (QC) testing have historically been defined by the CLIA test complexity categorizations: high complexity, moderate complexity, or waived. These categorizations are assigned...
...with the intention of obtaining waived status under the Clinical Laboratory Improvement Amendments (CLIA). The assays are simple, require no sample preparation or measurement, and are highly reliable. No technical training is required for operation of the system. In traditional immunoassays, colored...
Engineering Web Search: CLIA Waived
Recommendations: Clinical Laboratory Improvement Amendments of...
Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
Follow Good Laboratory Practices with Waived Laboratory Tests
Simple tests designated as waived can be used by laboratories that enroll in CLIA and pay the fee but are exempt from CLIA '88 standards (i.e.
COLA - CLIA Facts Set 4: Waived & Provider-Performed...
Set of CLIA Facts that includes: CLIA Facts 11: Waived Testing
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High Quality Rapid Diagnostic Products Manufacture &...
OTC/CLIA-Waived Products Multi-Drug Tests CLIA Waived Drugs of Abuse Tests ? NEW!!
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BD (Becton, Dickinson and Company) - Diagnostic Systems
BD Veritor? System: CLIA-waived For Rapid Detection of Flu A+B
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BinaxNow Influenza A and B Test Kits (22... from Amazon.com
and elution solution vials (CLIA Waived tests also include sterile NP swabs) . 22 - Test Kit; CLIA Waived Labels: Binax Nodes: Microbiology Supplies,
Quickvue One Step HCG Urine Pregnancy Te... from Amazon.com
hundredths-pounds List Price: Amazon Price: Description: hCG-Urine, CLIA Waived, 25 tests/kit, Detects 25 mIU/mL in urine and serum.
? Select Lab (CLIA In-House Laboratory). ? Enter Results Date.
Tips on Waived Testing -- Running a Practice -- AAFP
Waived labs are required by CLIA to: Enroll in the CLIA program