Atlas FDA

GQO

16 FDA 510(k) clearances · Product code

204 daysmedian time to decision
526 days90th percentile
16clearances measured

FDA profile

Official device name
Antisera, Cf, Herpesvirus Hominis 1,2
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3305
Medical specialty
Microbiology
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RecordFirmDate
VIRGO HSV-2 IGG ELISA (K883281)Electro-Nucleonics, Inc.1989-03-10
VIRGO HSV-1 IGG ELISA (K883282)Electro-Nucleonics, Inc.1989-03-10
BION HSV1-G OR HSV2-G TEST SYSTEM (K881261)Bion Ent., Ltd.1988-06-07
THE DDI SERODOT HERPES IGG TEST KIT (K875366)Disease Detection International, Inc.1988-05-23
VIROGEN HSV ANTIBODY TEST (K871426)Armkel, LLC1987-10-15
THE GOLDEN QUAD TEST (HSV) (K861120)Microbiological Research Corp.1987-02-02
VISIBLE-HERPES TM TEST SYSTEM (K854712)Isolab, Inc.1986-05-20
HSVI - IGG ELISA-KIT (K852782)Clinical Sciences, Inc.1986-01-21
HSV2 - IGG ELISA-KIT (K852781)Clinical Sciences, Inc.1986-01-21
AMIZYME-HSV TYPES 1 & 2 TEST KITS (K842531)Amico Lab, Inc.1985-12-06
ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (K842663)Amico Lab, Inc.1985-12-06
HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT (K852931)Microbix Biosystems, Inc.1985-11-12
ENZYGNOST ANTIHERPES SIMPLEX VIRUS (K841245)Behring Diagnostics, Inc.1985-11-05
VIROGEN HERPES SLIDE TEST (K852928)Armkel, LLC1985-10-17
HERPES VIRUS AGGLUTINATION TEST (K842887)Scientific Research1985-02-26
ANTIBODY TO HERPESVIRUS HOMINIS (K791058)Electro-Nucleonics Laboratories, Inc.1979-09-07

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