FDA.reportPublic FDA data

FITC TdT Reagent

Primary DI
B7826100D03
Brand
FITC TdT Reagent
Company
Supertechs, Inc.
Model
6100D
Catalog number
6100D
Device description
Analyte Specific ReagentFITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a)10.0 mL bottle for approximately 1000 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
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7826100D03PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Terminal deoxynucleotidyl transferase (TdT) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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, Specify00Avoid exposure to light
Storage Environment Temperature0 Degrees Celsius-20 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
B7828100A02FITC TdT Negative Control IgG18100A81002023-07-31
B7828200A03FITC TdT Negative Control IgG2a8200A82002023-07-31
B7829500A07TdT Control Cell Suspension9500A95002019-10-08
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
Primary DIBrandCompanyProduct codePublished
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00810034704337Spark Violet™ 423 anti-human CD45BIOLEGEND, INC.MVU2026-07-06
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05055844935761CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
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