FDA.reportPublic FDA data

IFA Mosaic: Coxsackie virus B Types (IgG)

Primary DI
04049016061311
Brand
IFA Mosaic: Coxsackie virus B Types (IgG)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
FI 2730-1005-3 G
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GNMAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNMAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-6Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016061311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016061311040490160613114049016061311

GMDN Terms#

Term, Definition table
TermDefinition
Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to multiple Coxsackie viruses of subgroups A and B in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
322209263
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049016158547Anti-Measles Virus ELISA 2.0 (IgG)EI 2610-9601-2 G2026-05-29
04049016152071TITERPLANE set for the incubation of slides with 10 fieldsZZ 9999-0101-18-R2026-05-11
04049016152118Coded reagent tray for slides with 10 fieldsZZ 9999-0110-12-R2026-05-11
04049016152132Coded reagent tray for slides with 50 fieldsZZ 9999-0150-13-R2026-05-11
04049016152156Coded glass plates for the incubation of slides with 10 fieldsZZ 9999-0510-15-R2026-05-11
04049016152163Coded glass plates for the incubation of slides with 50 fieldsZZ 9999-0550-16-R2026-05-11
04049016155638Incubation tray 44 channels, blackZD 9892-30442026-05-11
04049016151302FITC-labelled anti-human IgA with Evans BlueAF 601-0540-R2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueAF 602-0540-R2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueAF 602-0546-R2026-02-10
04049016026976ANA Screen ELISA (IgG)EA 1590-9601-8 G2016-09-24
04049016045335ANA IFA: HEp-20-10FA 1522-10032016-09-24
04049016045342ANA IFA: HEp-20-10FA 1522-10052016-09-24
04049016045359ANA IFA: HEp-20-10FA 1522-10102016-09-24
04049016045366ANA IFA: HEp-20-10FA 1522-10502016-09-24
04049016045380ANA IFA: HEp-20-10FA 1522-20032016-09-24
04049016045397ANA IFA: HEp-20-10FA 1522-20052016-09-24
04049016045403ANA IFA: HEp-20-10FA 1522-20102016-09-24
04049016099017IFA 40: HEp-20-10FA 1522-1010-12016-09-24
04049016099024IFA 40: HEp-20-10FA 1522-2005-12016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049016060994IFA Mosaic: Coxsackie virus (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04049016061151IFA Mosaic: Coxsackie virus A Types (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04049016061175IFA Mosaic: Coxsackie virus A Types (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04049016061335IFA Mosaic: Coxsackie virus B Types (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04049016061472IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04049016061489IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04049016080787IFA Mosaic: Coxsackie virus A Types (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04061841171218Light Diagnostics ™ Coxsackie B Control SlideEMD Millipore CorporationGNM2022-12-01
04061841171737Light Diagnostics ™ Coxsackie A9/A24 Control SlideEMD Millipore CorporationGNM2022-12-01
04053252404290Light Diagnostics ™ Coxsackievirus A Control SlidesEMD Millipore CorporationGNM2022-11-30
04053252729225Light Diagnostics ™ Coxsackievirus B Control Slides EMD Millipore CorporationGNM2022-11-30
04053252326011Light Diagnostics™ Coxsackievirus A24 Monoclonal AntibodyEMD Millipore CorporationGNM2022-11-29
04053252326264Light Diagnostics ™ Coxsackievirus B1 Monoclonal AntibodyEMD Millipore CorporationGNM2022-11-29
04053252332371Light Diagnostics ™ Coxsackievirus B5 Monoclonal AntibodyEMD Millipore CorporationGNM2022-11-29
04053252404719Light Diagnostics ™ Coxsackievirus B3 Monoclonal AntibodyEMD Millipore CorporationGNM2022-11-29
04053252408489Light Diagnostics ™ Coxsackievirus B4 Monoclonal AntibodyEMD Millipore CorporationGNM2022-11-29
04053252516092Light Diagnostics ™ Coxsackievirus B2 Monoclonal AntibodyEMD Millipore CorporationGNM2022-11-29
04053252585258Light Diagnostics ™ Coxsackie Antibody SetEMD Millipore CorporationGNM2022-11-29
04053252672989Light Diagnostics™ Coxsackievirus A9 Monoclonal AntibodyEMD Millipore CorporationGNM2022-11-29
04053252734557Light Diagnostics ™ Coxsackievirus B Blend Monoclonal AntibodiesEMD Millipore CorporationGNM2022-11-29
04053252472985Light Diagnostics ™ Coxsackievirus B6 Monoclonal AntibodyEMD Millipore CorporationGNM2022-09-24