FDA.reportPublic FDA data

LT ABO_Rh (D) Blood Grouping Card

Primary DI
06974621793136
Brand
LT ABO_Rh (D) Blood Grouping Card
Company
Zhuhai Longtime Biological Technology Co., Ltd
Model
BGC-8
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
KSYBoxes, View, Blood Grouping

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSYBoxes, View, Blood GroupingHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974621793133PackageGS11In Commercial Distribution
06974621793136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697462179313316974621793133
06974621793136069746217931366974621793136

GMDN Terms#

Term, Definition table
TermDefinition
ABO/Rh multiple blood grouping IVD, kit, agglutinationA collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen for a combination of multiple ABO system and Rh group red blood cell antigens, using an agglutination method.

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
06974621793143LT Blood Cross Matching CardBCM-62023-08-01
06974621793150LT Blood Cross Matching CardBCM-82023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974621793228LT Reagent Cards IncubatorZhuhai Longtime Biological Technology Co., LtdKSY2025-06-06
06974621793396LT Brucella Antibody Test Kit (Microcolumn Gel Method)Zhuhai Longtime Biological Technology Co., LtdKSY2025-06-06
56974621793223LT Reagent Cards IncubatorZhuhai Longtime Biological Technology Co., LtdKSY2025-06-06
16974621793393LT Brucella Antibody Test Kit (Microcolumn Gel Method)Zhuhai Longtime Biological Technology Co., LtdKSY2025-06-06
06974621793129LT ABO_Rh (D) Blood Grouping CardZhuhai Longtime Biological Technology Co., LtdKSY2023-08-01
06974621793143LT Blood Cross Matching CardZhuhai Longtime Biological Technology Co., LtdKSY2023-08-01
06974621793150LT Blood Cross Matching CardZhuhai Longtime Biological Technology Co., LtdKSY2023-08-01
06974621793167LT Rh Phenotype CardZhuhai Longtime Biological Technology Co., LtdKSY2023-08-01
06974621793174LT Rh Phenotype CardZhuhai Longtime Biological Technology Co., LtdKSY2023-08-01