Atlas FDA

GQL

37 FDA 510(k) clearances · Product code

94 daysmedian time to decision
303 days90th percentile
37clearances measured

FDA profile

Official device name
Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3305
Medical specialty
Microbiology
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RecordFirmDate
ELVIS HSV ID AND D3 TYPING TEST SYSTEM (K091753)Diagnostic Hybrids, Inc.2009-08-28
LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT (K081527)Millipore Corporation2009-04-01
THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH (K984120)Zeus Scientific, Inc.1999-05-26
THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K984135)Zeus Scientific, Inc.1999-05-26
INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (K905608)Stellar Bio Systems, Inc.1991-11-07
HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING (K904095)California Integrated Diagnostics, Inc.1991-02-01
PATHODX HERPES TYPING (K904167)Diagnostic Products Corp.1990-12-13
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 (K902661)Baxter Healthcare Corp1990-07-31
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST (K902662)Baxter Healthcare Corp1990-07-31
HSV-2 ELISA TEST SYSTEM (K891782)Zeus Scientific, Inc.1989-06-20
HSV-1 ELISA TEST SYSTEM (K891162)Zeus Scientific, Inc.1989-06-20
ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES (K891382)Ortho Diagnostic Systems, Inc.1989-06-06
HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 (K870814)Microscan Div. Baxter Healthcare Corp.1987-06-04
DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST (K851635)Diagnon Corp.1985-10-10
ORTHO DNA PROBE HSV CONFIRMATION TEST (K852360)Ortho Diagnostic Systems, Inc.1985-09-12
PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP (K852125)Kallestad Laboratories, Inc.1985-07-30
CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS (K851372)Difco Laboratories, Inc.1985-07-12
GIBCO HERPES ID KIT (K841943)Gibco Laboratories Life Technologies, Inc.1985-03-13
AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT (K850739)Syva Co.1985-03-11
CULTURESET HSV ISOLATION & ID SYS (K842216)Ortho Diagnostic Systems, Inc.1985-01-29
MICROTRAK HSV 1 & 2 DIRECT SPECIMAN (K841190)Syva Co.1985-01-18
SCOTT SELECTICULT-HSV ISOLATION & (K841680)Scott Laboratories, Inc.1984-10-30
MICROTRAK HSV 1 & 2 CULTURE (K840494)Syva Co.1984-05-07
HERPES IDENT. & TYPING TEST HITT (K831504)Electro-Nucleonics Laboratories, Inc.1983-09-20
HSV IGM TEST (K830865)Gull Laboratories, Inc.1983-07-18
INDIRECT FLUORO-KIT HSV (K830623)Clinical Sciences, Inc.1983-07-07
HERPES SIMPLEX VIRUS TYPING REAGENTS (K830971)Immulok, Inc.1983-06-30
MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION (K830953)Syva Co.1983-06-22
FLUOROSET IMMUNOFLUORESCENT ANTIBODY (K822785)Immulok, Inc.1982-11-29
HISTOSET IMMUNOPEROFIDASE TISSUE (K821411)Immulok, Inc.1982-06-25
IMMULOK CULTURESET (K821567)Immulok, Inc.1982-06-25
HERPES VIRUS HOMINIS ANTIBODY TEST SYS. (K812085)Zeus Scientific, Inc.1981-09-01
DIRECT FLUORESCENT ANTIBODY KIT/HERPES (K802590)Bartels & Stout, Inc.1981-02-09
HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT (K803132)Microbiological Research Corp.1981-01-28
FIAX TEST KIT FOR HERPES SIMPLEX VIRUS (K792559)Intl. Diagnostic Technology1980-03-03
HERPES I.D. TM TEST (K771445)Hyland Therapeutic Div., Travenol Laboratories1977-12-14
HSV TEST (K771063)Gull Laboratories, Inc.1977-07-11

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