FDA.reportPublic FDA data

LT Brucella Antisera Test Reagents

Primary DI
06974621793235
Brand
LT Brucella Antisera Test Reagents
Company
Zhuhai Longtime Biological Technology Co., Ltd
Model
BAT-A
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
06974621793235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974621793235069746217932356974621793235

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
06974621793242LT 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