FDA.reportPublic FDA data

D3

Primary DI
30014613330646
Brand
D3
Company
DIAGNOSTIC HYBRIDS, INC.
Model
01-057005
Catalog number
01-057005
Device description
D3 DFA ENTERO 71 REAGENT
Published
2019-04-19
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
GOEANTISERA, FLUORESCENT, POLIOVIRUS 1-3

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GOEAntisera, Fluorescent, Poliovirus 1-3Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613330646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333064630014613330646

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory virus antigen IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens from viruses associated with respiratory diseases in a clinical specimen, using a fluorescent immunoassay method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117359612
Device count
1
Premarket exempt
true
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
30014613330486D3DIAGNOSTIC HYBRIDS, INC.GOE2023-07-10
04053252286612Light Diagnostics ™ Pan-Enterovirus Control SlidesEMD Millipore CorporationGOE2022-12-05
04053252471827Light Diagnostics ™ Pan-Enterovirus Reagent EMD Millipore CorporationGOE2022-12-05
04061841171201Light Diagnostics ™ Poliovirus Control SlideEMD Millipore CorporationGOE2022-12-05
04061841171478Light Diagnostics ™ Enterovirus70/71 Control SlideEMD Millipore CorporationGOE2022-12-05
04053252476464Light Diagnostics ™ Poliovirus Control SlidesEMD Millipore CorporationGOE2022-11-30
04053252625091Light Diagnostics ™ Enterovirus 70/71 Control Slides EMD Millipore CorporationGOE2022-11-30
04053252675706Light Diagnostics ™ Enterovirus Slide PackageEMD Millipore CorporationGOE2022-11-30
04061839700550Light Diagnostics ™ Pan-Enterovirus Control SlideEMD Millipore CorporationGOE2022-11-30
04053252277030Light Diagnostics ™ Pan-Enterovirus 2E11 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
04053252279973Light Diagnostics ™ Enterovirus Screening KitEMD Millipore CorporationGOE2022-11-29
04053252280085Light Diagnostics ™ Pan-Enterovirus Detection KitEMD Millipore CorporationGOE2022-11-29
04053252321078Light Diagnostics ™ Enterovirus 70 and 71 or Coxsackie A16 BlendEMD Millipore CorporationGOE2022-11-29
04053252321696Light Diagnostics ™ Poliovirus Antibody SetEMD Millipore CorporationGOE2022-11-29
04053252338243Light Diagnostics ™ Poliovirus BlendEMD Millipore CorporationGOE2022-11-29
04053252369407Light Diagnostics ™ Poliovirus 1 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
04053252469404Light Diagnostics ™ Enterovirus 71/ Coxsackie A16 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
04053252474262Light Diagnostics ™ Pan-Enterovirus 9D5EMD Millipore CorporationGOE2022-11-29
04053252581069Light Diagnostics ™ Pan-Enterovirus Reagent EMD Millipore CorporationGOE2022-11-29
04053252619441Light Diagnostics ™ Enterovirus 70 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
04053252624155Light Diagnostics ™ Enterovirus 71 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
04053252671012Light Diagnostics ™ Enterovirus 70/71 Antibody SetEMD Millipore CorporationGOE2022-11-29
04053252673146Light Diagnostics ™ Poliovirus 3 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
04053252677649Light Diagnostics ™ Poliovirus 2 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
08436037124600Light Diagnostics ™ Enterovirus Screening SetEMD Millipore CorporationGOE2022-11-29
30014613330653D3DIAGNOSTIC HYBRIDS, INC.GOE2019-04-19
30014613330561D3DIAGNOSTIC HYBRIDS, INC.GOE2019-03-07
30014613330578D3DIAGNOSTIC HYBRIDS, INC.GOE2019-03-07
30014613330585D3DIAGNOSTIC HYBRIDS, INC.GOE2019-03-07
30014613330592D3DIAGNOSTIC HYBRIDS, INC.GOE2019-03-07