Sysmex Automated Blood Coagulation Analyzer CS-5100

FDA 510(k)

FDA Class 2 ·Hematology

PROFIL CONDOM (RUBBER LATEX)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BBL CHROMAGAR 0157

FDA 510(k)

FDA Class 1 ·Microbiology

CUFF-ABLE PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

BBL ANAGEL POWDER

FDA 510(k)

FDA Class 1 ·Microbiology

BBL GASPAK POUCH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROFILE BBL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BBL CAMPY POUCH

FDA 510(k)

FDA Class 1 ·Microbiology

ABL 735 ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABL SYSTEM 620

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABLE GENERATION DESK

FDA 510(k)

FDA Class 1 ·Physical Medicine

BBL STAPHYSLIDE TEST

FDA 510(k)

FDA Class 1 ·Microbiology

BBL MGIT PRODUCTS

FDA 510(k)

FDA Class 1 ·Microbiology

BBL PNEUMOSLIDE TEST

FDA 510(k)

FDA Class 1 ·Microbiology

Genemed®

FDA UDI

SAKURA FINETEK U.S.A., INC.·00615233002976·Sensitive DAB Kit, Ready-To-Use, 100 mL each

N/A

FDA UDI

HARDY DIAGNOSTICS·00819398028592·C. diff PRO, a rapid proline and indole test fo...

PolyDetector HRP Black kit

FDA UDI

BIO SB, INC.·B502BSB0090C0·PolyDetector HRP Black Substrate-Chromogen used...

PolyDetector HRP Blue kit

FDA UDI

BIO SB, INC.·B502BSB01450·PolyDetector HRP Blue Substrate-Chromogen Kit i...

PolyDetector HRP Green kit

FDA UDI

BIO SB, INC.·B502BSB01330·PolyDetector HRP Green Substrate-Chromogen Kit ...

PolyDetector DAB HRP Brown Chromogen

FDA UDI

BIO SB, INC.·B502BSB0019C0·DAB (3’3’diaminobenzidine) chromogen