FDA.reportPublic FDA data

LT Brucella Antisera Test Reagents

Primary DI
06974621793242
Brand
LT Brucella Antisera Test Reagents
Company
Zhuhai Longtime Biological Technology Co., Ltd
Model
BAT-B
Published
2023-08-01
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
06974621793242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974621793242069746217932426974621793242

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Brucella species total antibody IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to multiple species of Brucella bacteria in a clinical specimen, using an agglutination method. It is commonly used for the detection of infection with or exposure to Bordetella bacteria which may include B. abortus and B. melitensis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
708328288
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
06974621793006LT Kit for PRPPRP-B12023-06-05
06974621793037LT Kit for PRPPRP-B22023-06-05
06974621793204LT Medical Centrifuge for Blood Grouping CardLTA-12A 2023-06-05
06974621793211LT Medical Centrifuge for Blood Grouping CardLTA-24A 2023-06-05
06974621793259LT Kit for PRPPRP1012025-06-09
06974621793266LT Kit for PRPPRP1512025-06-09
06974621793273LT Kit for PRPPRP1522025-06-09
06974621793280LT Kit for PRPPRP2012025-06-09
06974621793297LT Kit for PRPPRP2022025-06-09
06974621793303LT Kit for PRPPRP2512025-06-06
06974621793310LT Kit for PRPPRP2522025-06-06
06974621793327LT Kit for PRPPRP3012025-06-06
06974621793334LT Tube for PRPPRP102025-06-06
06974621793341LT Tube for PRPPRP152025-06-06
06974621793358LT Tube for PRPPRP202025-06-06
06974621793365LT Tube for PRPPRP252025-06-06
06974621793372LT Tube for PRPPRP302025-06-06
06974621793129LT ABO_Rh (D) Blood Grouping CardBGC-62023-08-01
06974621793136LT ABO_Rh (D) Blood Grouping CardBGC-82023-08-01
06974621793143LT Blood Cross Matching CardBCM-62023-08-01

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
B350GSD0130070GSD Brucella IgG ELISAGold Standard Diagnostics CorporationGSM2017-07-12
04049016027553Anti-Brucella abortus ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGGSM2016-09-24
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