247 results · 23ms · Sources: EU EUDAMED, US FDA

Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit

FDA 510(k)
FDA Class 2 ·Microbiology

IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

LYME STAT M TEST KIT

FDA 510(k)
FDA Class 2 ·Microbiology

LYME-SPOT IF KIT

FDA 510(k)
FDA Class 2 ·Microbiology

Borrelia B31 ViraChip IgM Test Kit

FDA 510(k)
FDA Class 2 ·Microbiology

MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit

FDA 510(k)
FDA Class 2 ·Microbiology

Sofia Lyme FIA, Sofia Lyme Control Set

FDA 510(k)
FDA Class 2 ·Microbiology

QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024

FDA 510(k)
FDA Class 2 ·Microbiology

ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

LYME DISEASE ELISA

FDA 510(k)
FDA Class 2 ·Microbiology

Reagent, Borrelia Serological Reagent

FDA classification
FDA Class 2 ·Reagent, Borrelia Serological Reagent

ASR-3520 SKIN RESPONSE MONITOR;ASR-3520A

FDA 510(k)
FDA Class 2 ·Neurology

DIGITAL IMAGING SYSTEM (BSR)

FDA 510(k)
FDA Class 2 ·Radiology

ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR LSD TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

STC DIAGNOSTICS LSD MICRO-PLATE EIA

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology