PSZ

Product Code: PSZ


Products Classified as PSZ

3579Devices Detecting Influenza A, B, And C Virus AntigensInfluenza Virus Antigen Detection Test System.

Total Product Life Cycle (TPLC) Devices

3579Devices Detecting Influenza A, B, And C Virus AntigensInfluenza Virus Antigen Detection Test System.

Pre-market Notifications for PSZ

K192719Osom Ultra Plus Flu A&B Test KitSekisui Diagnostics, LLC
K191514CareStart Flu A&B PlusAccess Bio, Inc.
K182157BioSign Flu A+BPrinceton BioMeditech Corp.
K182001Acucy Influenza A&B Test With The Acucy SystemSekisui Diagnostics, LLC
K181853Alere BinaxNOW Influenza A & B Card 2, Alere ReaderAlere Scarborough, Inc.
K180438BD Veritor System For Rapid Detection Of Flu A + B CLIA Waived KitBD
K180288QuickVue Influenza A+BQuidel Corporation
K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.
K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitALERE SCARBOROUGH, INC.
K162438Sofia Influenza A+B FIA On Sofia 2Quidel Corporation
K160164BD Veritor System For Rapid Detection Of Flu A + B Labratory KitBecton, Dickinson & Co.
K160161BD Veritor System For Rapid Detection Of Flu A + B CLIA Waived KitBecton, Dickinson & Co.
K153012Sofia Influenza A+B FIAQUIDEL CORPORATION
K152870BD Veritor System For The Rapid Detection Of Flu A + B CLIA Waived KitBECTON DICKINSON AND CO.
K152874BD Veritor System For The Rapid Detection Of Flu A + B Laboratory KitBECTON DICKINSON, AND CO.

Global Unique Device Identification Database

00742860100239Devices detecting influenza A, B, and C virus antigens
00742860100222Devices detecting influenza A, B, and C virus antigens
00895160002526Devices Detecting Influenza A, B, And C Virus Antigens
10854916006802Devices Detecting Influenza A, B, And C Virus Antigens
10854916006796Devices Detecting Influenza A, B, And C Virus Antigens
00742860100345Devices Detecting Influenza A, B, And C Virus Antigens
00742860100338Devices Detecting Influenza A, B, And C Virus Antigens
00742860100383Devices Detecting Influenza A, B, And C Virus Antigens
00742860100376Devices Detecting Influenza A, B, And C Virus Antigens
00840733101656Devices Detecting Influenza A, B, And C Virus Antigens
00840733101649Devices Detecting Influenza A, B, And C Virus Antigens
03848838027038Devices Detecting Influenza A, B, And C Virus Antigens
30848838027032Devices Detecting Influenza A, B, And C Virus Antigens
10742860100397Devices Detecting Influenza A, B, And C Virus Antigens
10811877010989Devices Detecting Influenza A, B, And C Virus Antigens

Maude Adverse Events

QUICKVUE INFLUENZA A+BQUIDEL CORPORATION2020-02-27
BD VERITOR? SYSTEM FOR RAPID DETECTION OF FLU A+B, 30 TESTSBD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.2020-01-29
SOFIA INFLUENZA A+B FIAQUIDEL CORPORATION2018-02-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.