Atlas FDA

GQN

34 FDA 510(k) clearances · Product code

138 daysmedian time to decision
359 days90th percentile
34clearances measured

FDA profile

Official device name
Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3305
Medical specialty
Microbiology
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RecordFirmDate
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 (K070265)Diagnostic Hybrids, Inc.2007-10-24
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 (K063798)Diagnostic Hybrids, Inc.2007-09-21
LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY (K991880)Light Diagnostics1999-11-09
ELVIS HSV ID/TYPING TEST SYSTEM (K971662)Diagnostic Hybrids, Inc.1997-11-18
HSV-1 ANTIGEN CONTROL SLIDES (K964874)Viral Antigens, Inc.1997-07-01
HSV-2 ANTIGEN CONTROL SLIDES (K971101)Viral Antigens, Inc.1997-07-01
ELVIS HSV GOLD (K960578)Diagnostic Hybrids, Inc.1996-09-05
ELVIS HSV (K941924)Diagnostic Hybrids, Inc.1995-05-01
HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT (K911345)Diagnostic Hybrids, Inc.1991-06-17
MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. (K884761)Difco Laboratories, Inc.1988-12-05
HERPES VIRUS CONTROL SLIDES (K883684)Val Tech Diagnostics, Inc.1988-09-28
HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT (K873529)Diagnostic Hybrids, Inc.1988-08-25
WELLCOZYME HSV WZO2 (K875311)Wellcome Diagnostics1988-08-03
COLORGENE HSV DNA HYBRIDIZATION TEST (K880604)Enzo Biochem, Inc.1988-08-03
FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG (K881180)Whittaker Bioproducts, Inc.1988-05-13
FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG (K880996)Whittaker Bioproducts, Inc.1988-05-13
DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT (K872632)E.I. Dupont DE Nemours & Co., Inc.1988-02-18
MICROTRAK HSV CULTURE IDENTIFICATION TEST (K880436)Syva Co.1988-02-18
RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) (K874863)Monoclonal Antibodies, Inc.1988-02-16
COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. (K870733)Enzo Biochem, Inc.1987-05-26
IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST (K870602)Boots-Celltech Diagnostics, Inc.1987-05-08
HSV IDR (K854974)Genus Diagnostics1986-03-07
ORTHO HSV ANTIGEN ELISA TEST (K854488)Ortho Diagnostic Systems, Inc.1986-02-04
DIRECT ELISA FOR HERPES SIMPLEX VIRUS (K853307)Fairleigh Dickinson Laboratories, Inc.1985-12-23
IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF (K842830)Bartels Immunodiagnostic Supplies, Inc.1985-11-26
H. SIMPLEX VIRUS (K843658)Institute Virion , Ltd.1985-09-26
HERPES SIMPLEX GROUP CF ANTIGEN (K850609)Hillcrest Biologicals1985-05-09
CORDIA HS ANTIBODY TYPING REAGENTS (K843751)Cordis Corp.1985-04-24
MICROTRAKSPECIMAN ID TYPING TEST CONTR (K841191)Syva Co.1984-06-19
SIMPLEX-2 (K832541)Gentech Australia1984-02-04
CORDIA HS (K832875)Cordis Corp.1983-11-28
HERPES (K811021)Immuno-Diagnostic Products, Inc.1981-11-05
HSV BIO-BEAD TITRATION KIT (K801721)Litton Bionetics1980-09-16
HSV BIO-BEAD SCREEN KIT (K791614)Litton Bionetics1979-11-13

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