Panels › Microbiology › Product code GMZ · Class 1
Antigens, All Types, Escherichia Coli
Regulation 866.3255
0510(k)s in 12 months (14 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in GMZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Meridian Bioscience, Inc. | 3 | 0 |
| Techlab Inc., Corporate Research Center | 2 | 0 |
| Alexon - Trend, Inc. | 1 | 0 |
| Guardian Scientific, Corp. | 1 | 0 |
| Hardy Media Inc Dba Hardy Diag | 0 | 1 |
| Inverness Medical-Biostar, Inc. | 1 | 0 |
| Lmd Laboratories | 1 | 0 |
| Medi-Tech, Inc. | 1 | 0 |
| Meridian Diagnostics, Inc. | 1 | 0 |
| Murex Biotech , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2006 | Hardy Media Inc Dba Hardy Diag HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455 Terminated |
GMZ | None listed |
| Aug 17, 2004 | Remel, Inc. ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX 2) in aqueous extracts of Terminated |
GMZ | K980507 |
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