Product code GQS— Microbiology
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1
- Classification name
- Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
- Device class
- Class 1
- Regulation
- 21 CFR 866.3400
- Advisory panel
- Microbiology
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code GQS
FDA has cleared devices under product code GQS between 1980 and 2009, filed by 7 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2009
- 1995
- 1991
- 1988
- 1987
- 1985
- 1980
Top applicants under product code GQS
Recent clearances under product code GQS
- K093415 — D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
- K943557 — IMAGEN
- K905385 — P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN
- K884193 — PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT
- K884194 — PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT
- K871228 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2
- K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3
- K871234 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1
- K843665 — PARAINFLUENZA 1
- K843667 — PARAINFLUENZA 3
- K802935 — PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR
Data sourced from openFDA. This site is unofficial and independent of the FDA.