LIGHT DIAGNOSTICS RABIES DFA REAGENT

FDA 510(k)

FDA Class 2 ·Microbiology

VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

NEIGON JEMBEC PLATE WITH ANIXOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL)

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

FDA 510(k)

FDA Class 2 ·Immunology

KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-SM

FDA 510(k)

FDA Class 2 ·Immunology

VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

VITROS Immunodiagnostic Products Syphilis Reagent Pack

FDA 510(k)

FDA Class 2 ·Microbiology

Cue COVID-19 Molecular Test

FDA 510(k)

FDA Class 2 ·Microbiology

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz

FDA 510(k)

FDA Class 2 ·Immunology

DIRECTIGEN MENINGITIS COMBO TEST

FDA 510(k)

FDA Class 2 ·Microbiology

AXSYM TOXO IGM

FDA 510(k)

FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin

FDA 510(k)

FDA Class 2 ·Microbiology

REVISED C-REACTIVE PROTEIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME

FDA 510(k)

FDA Class 2 ·Microbiology

CEFTAZIDIME 30MCG. SENI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology