FDA.reportPublic FDA data

Anti-Brucella abortus ELISA (IgA)

Primary DI
04049016027553
Brand
Anti-Brucella abortus ELISA (IgA)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
EI 2189-9601 A
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GSMAntisera, Fluorescent, Brucella Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GSMAntisera, Fluorescent, Brucella Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016027553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016027553040490160275534049016027553

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
04049016152033WASH REAGENT 1ZM 0121-0050-R2026-10-30
04049016099017IFA 40: HEp-20-10FA 1522-1010-12016-09-24
04049016099055IFA 40: HEp-20-10FA 1522-1050-12016-09-24
04049016145646EURORealTime SARS-CoV-2MP 2606-01252020-08-04
04049016145653EURORealTime SARS-CoV-2MP 2606-02252020-08-04
04049016145660EURORealTime SARS-CoV-2MP 2606-04252020-08-04
04049016145691EURORealTime SARS-CoV-2MP 2606-01002020-08-04
04049016145745EURORealTime SARS-CoV-2MP 2606-02002020-08-04
04049016151272FITC-labelled anti-human IgG (primate absorbed)AF 302-0540-R2026-06-10
04049016151289Biotin-labelled anti-human IgGAF 402-0540-1-R2026-06-10
04049016151296FITC-labelled Avidin (biotin affine)AF 402-0540-2-R2026-06-10
04049016151630FITC-labelled anti-human IgG (primate absorbed)AF 302-0546-R2026-06-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIBRUG00500NovaLisa Brucella IgGGold Standard Diagnostics Frankfurt GmbHGSM2024-08-26
06974621793235LT Brucella Antisera Test ReagentsZhuhai Longtime Biological Technology Co., LtdGSM2023-08-01
06974621793242LT Brucella Antisera Test ReagentsZhuhai Longtime Biological Technology Co., LtdGSM2023-08-01
B350GSD0130070GSD Brucella IgG ELISAGold Standard Diagnostics CorporationGSM2017-07-12
04049016027560Anti-Brucella abortus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGSM2016-09-24
04049016027577Anti-Brucella abortus ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGSM2016-09-24
00695684011000BRUCELLA ABORTUS ANTISERUMGERMAINE LABORATORIES, INCGSM2016-04-12