FDA.reportPublic FDA data

FITC TdT Negative Control IgG1

Primary DI
B7828100A02
Brand
FITC TdT Negative Control IgG1
Company
Supertechs, Inc.
Model
8100A
Catalog number
8100
Device description
Analyte Specific Reagent FITC conjugated mouse IgG1 negative control 0.5 mL vial for approximately 50 tests
Published
2023-07-31
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
B7828100A02PrimaryHIBCC0

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, 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
B7826100D03FITC TdT Reagent6100D6100D2019-10-08
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
05055844935761CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
05055844935778CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
00810034704085FITC anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05
00810034704146PE/Cyanine7 anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05
00810034704160APC anti-human CD64BIOLEGEND, INC.MVU2026-06-05
00810034704177FITC anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704191PE/Cyanine7 anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704214APC anti-human CD31BIOLEGEND, INC.MVU2026-06-05
00810034704245APC anti-human CD274BIOLEGEND, INC.MVU2026-06-05
00810034704290APC/Fire™ 750 anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034702951PerCP/Cyanine5.5 anti-human Beta2-microglobulinBIOLEGEND, INC.MVU2026-06-01
00810034704061PE/Dazzle™ 594 anti-human CD22BIOLEGEND, INC.MVU2026-06-01
00810034704092FITC anti-human CD35BIOLEGEND, INC.MVU2026-06-01
00810034704108PE/Cyanine7 anti-human CD22BIOLEGEND, INC.MVU2026-06-01
00810034704139PE/Cyanine7 anti-human CD300eBIOLEGEND, INC.MVU2026-06-01
08595715450544CyFlow™ CD200 PE-Cy7EXBIO Praha, a.s.MVU2025-10-01
08719327450949Anti-HbF PUREIQ Products B.V.MVU2023-01-26
08719327450956Anti-HbF FITCIQ Products B.V.MVU2023-01-26
08719327450963Anti-HbF R-PEIQ Products B.V.MVU2023-01-26
08719327450970Anti-HbF Dy-410IQ Products B.V.MVU2023-01-26
08719327450987anti-HbS PUREIQ Products B.V.MVU2023-01-26
08719327450994anti-HbS FITCIQ Products B.V.MVU2023-01-26
08719327451014CD163 PURE IQ Products B.V.MVU2023-01-26
08719327451021CD163 FITCIQ Products B.V.MVU2023-01-26
08719327451038CD163 R-PEIQ Products B.V.MVU2023-01-26
08719327451045CD163 BiotinIQ Products B.V.MVU2023-01-26
08719327451052CD64 PUREIQ Products B.V.MVU2023-01-26
08719327451069CD64 CyQIQ Products B.V.MVU2023-01-26
08719327451076CD64 FITCIQ Products B.V.MVU2023-01-26
08719327451083CD64 R-PEIQ Products B.V.MVU2023-01-26