2,674 results · 33ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Automated Sample Transfer Processing System

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Luteinizing Hormone (LH) Rapid Test Kit (Immunochromatographic Assay)

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Disposable virus sampling Swab kits

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Sperm SP10 Protein Rapid Test Kit (Immunochromatographic Assay)

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Fecal Occult Blood (FOB) Rapid Test Kit (Immunochromatographic Assay)

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Fast real-time fluorescence PCR analyzer

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Trichomonas Vaginalis Antigen Rapid Test Kit (Immunochromatographic Assay)

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Follicle-stimulating Hormone (FSH) Rapid Test Kit (Immunochromatographic Assay)

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Candida Albicans Antigen Rapid Test Kit (Immunochromatographic Assay)

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Sterile Disposable Virus Sampling Kits

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Automatic Nucleic Acid Detection System

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Bio-Self COVID-19 Antigen Home Test

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Insulin-like Growth Factor Binding Protein-1 Rapid Test Kit (Colloidal Gold Method)

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Disposable Specimen Container

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Disposable Virus Sampling Swab Kits

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

Disposable specimen collection kit

FDA registration
BIOTEKE CORPORATION (WUXI) CO., LTD·1 product·🇨🇳 China

VPism-D+

FDA registration
IISM INC.·1 product·🇰🇷 South Korea

QUANTA Flash® Jo-1 Calibrators

FDA UDI
INOVA DIAGNOSTICS, INC.·08426950595724·1. QUANTA Flash Jo-1 Calibrator 1: Two (2) barc...

QUANTA Flash® Jo-1 Controls

FDA UDI
INOVA DIAGNOSTICS, INC.·08426950596011·1. QUANTA Flash Jo-1 Negative Control: Two (2) ...

AUTO I.D.® SSA/Ro and SSB/La Autoantibody Test System

FDA UDI
IMMUNO CONCEPTS INC·M7490600411·AUTO I.D.® Optional Control - Jo-1 - 1 x 0.5 ml