GNA
12 FDA 510(k) clearances · Product code
162 daysmedian time to decision
308 days90th percentile
12clearances measured
FDA profile
- Official device name
- Antisera, All Types, Escherichia Coli
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3255
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO BIOSTAR OIA SHIGATOX (K071799) | Iverness Medical Professional Diagnostics | 2007-10-02 |
| DUOPATH VEROTOXINS GLISA TEST (K031367) | Emd Chemicals, Inc. | 2004-01-23 |
| DRYSPOT E.COLI 0157 KIT (K993401) | Oxoid , Ltd. | 2000-02-28 |
| VTEC-RPLA SEIKEN (K981734) | Denka Seiken'S | 1998-09-22 |
| WELLCOLEX E-COLI OI57 ZC60 (K962028) | Murex Diagnostics, Inc. | 1996-11-01 |
| PREMIER EHEC (K953362) | Meridian Diagnostics, Inc. | 1995-11-14 |
| PREMIER EHEC (K950167) | Meridian Diagnostics, Inc. | 1995-04-14 |
| RIM E.COLI 0157:H7 LATEX TEST (K933457) | Remel Co. | 1994-04-20 |
| E. COLI 0157 LATEX TEST (K903714) | Pro-Lab, Inc. | 1991-01-24 |
| ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT (K884026) | Oxoid U.S.A., Inc. | 1989-02-03 |
| PHADEBACT ETEC-LT TEST (K874288) | Pharmacia, Inc. | 1988-09-02 |
| DIAGNOSTIC REAGENT VET-RPLA (K855234) | Oxoid U.S.A., Inc. | 1986-11-04 |
Track GNA automatically
Every clearance here is in the API, with alerts when new ones post.