GQS
11 FDA 510(k) clearances · Product code
91 daysmedian time to decision
374 days90th percentile
11clearances measured
FDA profile
- Official device name
- Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3400
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT (K093415) | Diagnostic Hybrids, Inc. | 2009-12-23 |
| IMAGEN (K943557) | Dako Diagnostics , Ltd. | 1995-01-09 |
| P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN (K905385) | Virion (U.S.), Inc. | 1991-03-21 |
| PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT (K884194) | Baxter Diagnostics, Inc. | 1988-11-22 |
| PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT (K884193) | Baxter Diagnostics, Inc. | 1988-11-22 |
| ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 (K871234) | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 (K871228) | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 (K871232) | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| PARAINFLUENZA 1 (K843665) | Institute Virion , Ltd. | 1985-09-26 |
| PARAINFLUENZA 3 (K843667) | Institute Virion , Ltd. | 1985-09-26 |
| PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR (K802935) | Orion Diagnostica, Inc. | 1980-12-31 |
Track GQS automatically
Every clearance here is in the API, with alerts when new ones post.