FDA.reportPublic FDA data

LT Reagent Cards Incubator

Primary DI
56974621793223
Brand
LT Reagent Cards Incubator
Company
Zhuhai Longtime Biological Technology Co., Ltd
Model
LTAFY-001
Published
2025-06-06
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
56974621793223PackageGS11Not in Commercial Distribution
06974621793228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5697462179322356974621793223
06974621793228069746217932286974621793228

GMDN Terms#

Term, Definition table
TermDefinition
Rhesus (Rh) phenotype (CcDEe) 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 to determine the Rh phenotype (CcDEe) [RH:1,2,3,4,5] of red blood cells, using an agglutination method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
708328288
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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
06974621793136LT 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