Atlas FDA

BD DIRECTIGEN EX FLU A+B

FDA 510(k) clearance K101461 · decided 2010-06-24

Clearance details

K-number
K101461
Device name
BD DIRECTIGEN EX FLU A+B
Applicant
Becton, Dickinson and Company
Decision
Substantially Equivalent
Date received
2010-05-26
Decision date
2010-06-24
Days to decision
29 days
Clearance type
Special
Product code
PSZ
Device class
2
Regulation number
866.3328
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
La Jolla, CA, US
Third-party review
No
Expedited review
No

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BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (K223016)Bd2023-01-27
Osom Ultra Plus Flu A&B Test Kit (K192719)SEKISUI Diagnostics, LLC2020-04-03
CareStart Flu A&B Plus (K191514)Access Bio, Inc.2020-02-18
Acucy Influenza A&B Test with the Acucy System (K182001)SEKISUI Diagnostics, LLC2018-12-17
BioSign Flu A+B (K182157)Princeton BioMeditech Corp.2018-09-18
Alere BinaxNOW Influenza A & B Card 2, Alere Reader (K181853)Alere Scarborough, Inc.2018-08-08
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (K180438)Bd2018-03-20
QuickVue Influenza A+B (K180288)Quidel Corporation2018-02-13

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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BD Onclarity HPV Assay (P160037/S023)Becton, Dickinson and Company2025-07-02
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BD Onclarity™ HPV Assay (P160037/S020)Becton, Dickinson and Company2024-11-05
BD Onclarity HPV Assay (P160037/S017)Becton, Dickinson and Company2024-05-14
BD Onclarity™ HPV Assay (P160037/S019)Becton, Dickinson and Company2024-04-18
BD Onclarity HPV Assay (P160037/S018)Becton, Dickinson and Company2023-11-20
BD Onclarity HPV (P160037/S016)Becton, Dickinson and Company2023-11-15