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GQS — Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 Class I

FDA Device Classification

Classification Details

Product Code
GQS
Device Class
Class I
Regulation Number
866.3400
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K093415diagnostic hybridsD3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KITDecember 23, 2009
K943557dako diagnosticsIMAGENJanuary 9, 1995
K905385virion (u.s.)P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGENMarch 21, 1991
K884193baxter diagnosticsPARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECTNovember 22, 1988
K884194baxter diagnosticsPARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECTNovember 22, 1988
K871234microscan div. baxter healthcareANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1June 26, 1987
K871232microscan div. baxter healthcareANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3June 26, 1987
K871228microscan div. baxter healthcareANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2June 26, 1987
K843665institute virionPARAINFLUENZA 1September 26, 1985
K843667institute virionPARAINFLUENZA 3September 26, 1985
K802935orion diagnosticaPARAINFLUENZA 1,2, & 3 ANTIGENS & CONTRDecember 31, 1980