FDA.reportPublic FDA data

LT Medical Centrifuge for Blood Grouping Card

Primary DI
06974621793204
Brand
LT Medical Centrifuge for Blood Grouping Card
Company
Zhuhai Longtime Biological Technology Co., Ltd
Model
LTA-12A
Published
2023-06-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
56974621793209PackageGS11Not in Commercial Distribution
06974621793204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5697462179320956974621793209
06974621793204069746217932046974621793204

GMDN Terms#

Term, Definition table
TermDefinition
Gel column agglutination centrifuge IVDAn electrically-powered device intended to be used in a clinical laboratory setting for the centrifugation of gel column agglutination cards used to perform manual blood typing assays. It is a dedicated compact benchtop unit with an electric motor, a shaft, a rotor with slots specifically shaped for use with gel column cards, and speed and time controls. The device is intended to centrifuge gel column agglutination cards for the manual determination of antigens of multiple blood systems (e.g., ABO, Rh, Kell) for compatibility testing and detection of unexpected antibodies.

Regulatory Flags#

DUNS number
708328288
Device count
1
Premarket exempt
true
Serial number
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
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
06974621793150LT Blood Cross Matching CardBCM-82023-08-01

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