510(k) K001364

BD DIRECTIGEN FLU A+B by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code PSZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 28, 2000
Date Received: May 1, 2000
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Devices Detecting Influenza A, B, And C Virus Antigens
Device Class: Class II
Regulation Number: 866.3328
Review Panel: MI
Submission Type

An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

K003062 — BACTEC MGIT 960 SIR KITS (June 6, 2001)
K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (March 21, 2001)
K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (February 1, 2001)
K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (November 29, 2000)
K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (April 25, 2000)
K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (April 13, 2000)
K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
K992734 — BECTON DICKINSON SYRINGE (October 1, 1999)
K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)
K991551 — VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE (September 23, 1999)

Other clearances for product code PSZ

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K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit (December 5, 2023)
K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (January 27, 2023)
K192719 — Osom Ultra Plus Flu A&B Test Kit (April 3, 2020)
K191514 — CareStart Flu A&B Plus (February 18, 2020)
K182001 — Acucy Influenza A&B Test with the Acucy System (December 17, 2018)
K182157 — BioSign Flu A+B (September 18, 2018)
K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader (August 8, 2018)