Culture Media, Multiple Biochemical Test
Microbiology · 21 CFR 866.2320
Recent MDR events
4 adverse event reports on file
- BD¿ SABOURAUD AGAR WITH GENTAMICIN AND CHLORAMPHENICOL, PLATE, 90 MM X 120MMJul 28, 2022MalfunctionBecton Dickinson Gmbh9680577-2022-00088
- MEDIUM COMPLEXITY MEDIA TEST KITFeb 23, 2021MalfunctionIvqaMW5099562
- BD BBL STERILE PACK PLATED MEDIAJan 26, 2021MalfunctionBecton, Dickinson & Co. (sparks)1119779-2021-00142
- BBL MEDIUM CULTURE 100ML TRYPTICASE SOY BROTHJan 25, 2021MalfunctionBecton Dickinson Gmbh9680577-2021-00003
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
Analytichem Usa, Inc.
Winslow, ME, US
Himedia Laboratories Private Limited
DOMBIVLI, THANE Maharashtra, IN
Legacy Biologicals
Baltimore, MD, US
Hardy Diagnostics
Orcutt, CA, US
Remel Europe Ltd
DARTFORD, KENT, GB
Remel, Inc.
LENEXA, KS, US
Himedia Laboratories Private Limited
NASHIK Maharashtra, IN
Hardy Diagnostics
Springboro, OH, US
510(k) clearances
53 clearances for this product code
- Dynatech Laboratories, Inc.Jul 25, 1996
K962265 · MLX MICROTITER PLATE LUMINOMETER
- Pro-Lab, Inc.Oct 12, 1988
K883996 · X-ACT LDC/IND
- Pro-Lab, Inc.Oct 12, 1988
K883995 · X-ACT UREA/TDA
- Hardy MediaMar 31, 1988
K880116 · MRVP BROTH
- Hardy MediaMar 31, 1988
K880133 · MIL MEDIUM
- Lakewood Biochemical Co., Inc.Nov 20, 1987
K874537 · KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
- bioMerieux, Inc.Apr 3, 1987
K871096 · CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES
- American Micro ScanJan 5, 1987
K864674 · MICRODILUTION IDENTIFICATION PANELS