Medical Device Manufacturer · US , Denville , NJ

Biotest Diagnostics Corp. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1996

Recent clearances: CMV BRITE TURBO KIT, BIOTEST ANTI-EBV RECOMBINANT, BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biotest Diagnostics Corp. Microbiology ✕

5 devices

1-5 of 5

Cleared Jul 12, 1999

CMV BRITE TURBO KIT

Microbiology · 60d

Cleared Jun 09, 1999

BIOTEST ANTI-EBV RECOMBINANT

Microbiology · 222d

Cleared Jun 09, 1999

BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG

Microbiology · 222d

Cleared Jun 09, 1999

BIOTEST ANTI-EBV RECOMBINANT, EA IGM

Microbiology · 222d

Cleared Jan 30, 1996

CMV BRITE ANTIGENEMIA TEST KIT

Microbiology · 301d