Lab and testing New

FDA categorizes each test system by complexity, and a site that tests human specimens for diagnosis must hold a CLIA certificate covering its tests, such as a Certificate of Waiver. Waived tests are listed as such only where FDA's CLIA database shows it, and they are supplied to sites that hold a certificate.

A cleared test has a 510(k) or De Novo decision. A test under an emergency use authorization is authorized, not cleared. Each listing states which, exactly as it applies, and performance figures are quoted only as printed in the package insert.

Tests cleared for over-the-counter home use can go to any account. Professional-use tests labeled Rx only go to laboratories, practitioners and facilities authorized under state law, and the restricted items rule applies to them.

Kits list tests per kit and whether swabs, reagents and controls are included or separate. A test that needs a reader states "Reader confirmed on quote". Each listing shows the kit contents.

Tests are perishable. Each listing states the storage temperature range, and each quote states the months of dating at shipment for the lot offered.

Evacuated tubes are chosen by additive: no additive or clot activator for serum, gel separator, K2 EDTA for hematology, sodium citrate for coagulation, heparin for plasma chemistry, fluoride and oxalate for glucose. Closure colors follow common United States convention and are stated with the additive on every listing.

Specimen containers are listed sterile or non-sterile, with closure type and any leak-resistant or tamper-evident claim, and transport bags with any 95 kPa pressure rating. Formalin-prefilled containers are hazardous in transport and carry a safety data sheet.