FDA.reportPublic FDA data

D3

Primary DI
30014613330691
Brand
D3
Company
DIAGNOSTIC HYBRIDS, INC.
Model
01-085005
Catalog number
01-085005
Device description
HSV MAB CONJUGATE
Published
2018-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GQNAntigen, cf (including cf control), herpesvirus hominis 1,2

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063798000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063798000DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000Diagnostic Hybrids, Inc.2007-09-21GQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613330691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333069130014613330691

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)552-1100technicalsupport@quidel.com

Regulatory Flags#

DUNS number
117359612
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30014613330288D3 Ultra01-010000.V201-010000.V22019-03-07
30014613330875D3 Fastpoint01-12350401-1235042019-03-07
00050428101735CVS Health At Home COVID-19 Test Kit204522895862025-08-08
30014613340089Savanna20382R20382R2024-07-19
30014613339304Savanna20382203822024-04-30
30014613340188CVS Health At Home COVID-19 Test Kit204522895862024-11-20
30014613330240D301-0005001-000502019-04-02
30014613311034LyraM103M1032016-09-15
30014613311157Quidel MolecularM115M1152018-11-16
30014613330752D3 FastpointRespiratory Virus ID Kit01-1200002016-09-15
30014613330769D3 Fastpoint01-120000.B101-120000.B12018-07-22
30014613330776D3 Fastpoint01-120000.B201-120000.B22018-07-22
30014613330813D3 FastpointRSV/MPV ID Kit01-1200022016-09-15
30014613330820D3 Fastpoint01-120002.B101-120002.B12018-07-22
30014613330837D3 Fastpoint01-120002.B201-120002.B22018-07-22
30014613336143SolanaM306M3062018-08-07
30014613338659D301-002007b01-002007b2019-04-23
30014613340119Savanna20445204452024-04-30
30014613340485SavannaM409-1M409-12024-04-30
30014613340492SavannaM409-4M409-42024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053252515101Light Diagnostics SimulFluor HSV 1/2 EMD Millipore CorporationGQN2020-04-16
04053252625213Light Diagnostics SimulFluor HSV 1/HSV 2 ReagentEMD Millipore CorporationGQN2020-04-16
30014613336013ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-04-02
30014613336020ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-04-02
30014613330110ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613330127ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613330158ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613330165ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613330196ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613330202ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613332954ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613332961ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613332978ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613332985ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613332992ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613333005ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613333012ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613333029ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613333036ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613333043ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613333050ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613333067ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613333074ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613333081ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613333098ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613330721D3DIAGNOSTIC HYBRIDS, INC.GQN2018-07-22
30014613330738D3DIAGNOSTIC HYBRIDS, INC.GQN2018-07-21
30014613330714D3DIAGNOSTIC HYBRIDS, INC.GQN2018-07-20
05700573075706NAOXOID LIMITEDGQN2016-09-24
04053252589942Light Diagnostics™ Simulfluor® HSV 1/ HSV 2 DFA KitEMD Millipore CorporationGQN2016-09-23