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510(k) K854081

IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST by Boots-Celltech Diagnostics, Inc. — Product Code GQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1986
Date Received
October 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

Other clearances by Boots-Celltech Diagnostics, Inc.

  • K871877 — IDEIA HERPES SIMPLEX VIRUS TEST (November 17, 1989)
  • K880799 — MODIFIED IDEIA CHLAMYDIA TEST (December 8, 1988)
  • K880758 — SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY (April 18, 1988)
  • K874875 — CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) (March 24, 1988)
  • K872958 — IMAGEN INFLUENZA VIRUS A AND B TESTMI (February 24, 1988)
  • K872843 — OVEIA (TM) DUAL ANALYTE (February 2, 1988)
  • K873625 — CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) (October 20, 1987)
  • K872056 — MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST (June 15, 1987)
  • K870602 — IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST (May 8, 1987)
  • K864998 — IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT (April 20, 1987)

Other clearances for product code GQG

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  • K240280 — Nano-Check™ RSV Test (July 30, 2024)
  • K162911 — Sofia RSV FIA on Sofia 2 analyzer (February 22, 2017)
  • K133140 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV (November 15, 2013)
  • K132456 — BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV (November 7, 2013)
  • K130398 — SOFIA(R) RSV FIA (August 13, 2013)
  • K121633 — BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV (September 18, 2012)
  • K101918 — QUICKVUE RSV 10 (September 24, 2010)
  • K101514 — BD DIRECTIGEN EZ RSV (July 9, 2010)
  • K091235 — RAMP RSV ASSAY (July 24, 2009)