Atlas FDA

BD DIRECTIGEN EZ FLU A+B ASSAY

FDA 510(k) clearance K101529 · decided 2010-06-14

Clearance details

K-number
K101529
Device name
BD DIRECTIGEN EZ FLU A+B ASSAY
Applicant
Becton, Dickinson & CO
Decision
Substantially Equivalent
Date received
2010-06-02
Decision date
2010-06-14
Days to decision
12 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

+ Add to Predicate Builder ◉ Watch Becton

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Nano-Check Influenza A+B Test (K252283)Nano-Ditech Corporation2026-01-15
Innovita Flu A/B Antigen Rapid Test (K250398)Innovita (Tangshan) Biological Technology Co., Ltd.2025-07-03
Acucy® Influenza A&B Test with the Acucy® 2 System (K241188)SEKISUI Diagnostics, LLC2025-04-18
BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit (K232434)Bd2023-12-05
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.