FDA.reportPublic FDA data

TdT Control Cell Suspension

Primary DI
B7829500A07
Brand
TdT Control Cell Suspension
Company
Supertechs, Inc.
Model
9500A
Catalog number
9500
Device description
Cell suspension containing fixed human lymphoblastoid REH (TdT+) and RA-1 (TdT-) cells50% TdT+ and 50% TdT- cells at a concentration of 2 x 10^7 cells/mL1.0 mL bottle for approximately 20 tests
Published
2019-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KIRCells, Animal And Human, Cultured

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIRCells, Animal And Human, CulturedHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7829500A07PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Terminal deoxynucleotidyl transferase (TdT) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of terminal deoxynucleotidyl transferase (TdT) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature4 Degrees Celsius4 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071245690
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
B7826100A00FITC TdT Reagent6100A61002019-10-08
B7826100C02FITC TdT Reagent6100C6100C2019-10-08
B7826100D03FITC TdT Reagent6100D6100D2019-10-08
B7828100A02FITC TdT Negative Control IgG18100A81002023-07-31
B7828200A03FITC TdT Negative Control IgG2a8200A82002023-07-31
B7826600C07FITC TdT Reagent6600C6600C2019-09-17
B7826600A05FITC TdT Reagent6600A66002019-09-16
B7826600D08FITC TdT Reagent6600D6600D2019-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04015630971961HPV 3 in 1 System Control SlidesVentana Medical Systems, Inc.KIR2021-01-29
05700573001736PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.KIR2020-11-17
05700571112755PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.KIR2020-11-17
30014613339571Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-10-02
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30014613331735Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
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30014613331773Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331780Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
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