Atlas FDA

GNW

16 FDA 510(k) clearances · Product code

74 daysmedian time to decision
214 days90th percentile
16clearances measured

FDA profile

Official device name
Antisera, Cf, Influenza Virus A, B, C
Device class
Class I (low risk)
Regulation
21 CFR 866.3330
Medical specialty
Microbiology
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RecordFirmDate
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT (K092882)Diagnostic Hybrids, Inc.2009-10-21
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (K092300)Diagnostic Hybrids, Inc.2009-08-28
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT (K081746)Diagnostic Hybrids, Inc.2008-12-23
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (K061101)Diagnostic Hybrids, Inc.2006-11-20
DFA RESPIRATORY VIRUS SCREENING & ID KIT (K022713)Diagnostic Hybrids, Inc.2002-12-18
BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT (K003204)Intracel Corp.2000-11-07
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B (K974302)Light Diagnostics1998-04-08
IMAGEN RESPIRATORY SCREEN (K973954)Dako Diagnostics , Ltd.1997-12-22
IMAGEN RESPIRATORY SCREEN (K962037)Dako Diagnostics , Ltd.1996-12-26
INFLUENZA A ANTIGEN TEST (K942172)Neogenex1994-07-06
INFLUENZA B ANITGEN TEST (K942174)Neogenex1994-06-30
INFLUENZA MAB TEST/INFLUENZA A TEST (K913351)Gull Laboratories, Inc.1991-12-17
INFLUENZA MAB TEST/INFLUENZA B TEST (K913214)Gull Laboratories, Inc.1991-12-13
VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY (K896635)Baxter Healthcare Corp1990-02-02
YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN (K872694)Sita, Inc.1987-09-18
INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN (K872693)Sita, Inc.1987-09-18

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Every clearance here is in the API, with alerts when new ones post.