SUPERTECHS, INC

Address:15800 Gaither Dr,Gaithersburg,MD,20877,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Reagents, Specific, Analyte (MVU) (6) Cells, Animal And Human, Cultured (KIR) (1)

Premarket Exempt

Yes

Clear

FITC TdT Reagent - B7826100A00 Catalog Number : 6100

Device Description : Analyte Specific ReagentFITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 Analyte Specific ReagentFITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a)0.5 mL vial for approximately 50 tests

Device Class : 1

Duns Number: 071245690

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

FITC TdT Reagent - B7826100C02 Catalog Number : 6100C

Device Description : Analyte Specific ReagentFITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 Analyte Specific ReagentFITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a)

Device Class : 1

Duns Number: 071245690

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

FITC TdT Reagent - B7826100D03 Catalog Number : 6100D

Device Class : 1

Duns Number: 071245690

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

FITC TdT Reagent - B7826600A05 Catalog Number : 6600

Device Description : Analyte Specific ReagentFITC conjugated mouse anti-human TdT clone 6 (IgG1)0.5 m Analyte Specific ReagentFITC conjugated mouse anti-human TdT clone 6 (IgG1)0.5 mL vial for approximately 50 tests

Device Class : 1

Duns Number: 071245690

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

FITC TdT Reagent - B7826600C07 Catalog Number : 6600C

Device Description : Analyte Specific ReagentFITC conjugated mouse anti-human TdT clone 6 (IgG1)

Device Class : 1

Duns Number: 071245690

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

FITC TdT Reagent - B7826600D08 Catalog Number : 6600D

Device Description : Analyte Specific ReagentFITC conjugated mouse anti-human TdT clone 6 (IgG1)10.0 Analyte Specific ReagentFITC conjugated mouse anti-human TdT clone 6 (IgG1)10.0 mL bottle for approximately 1000 tests

Device Class : 1

Duns Number: 071245690

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

TdT Control Cell Suspension - B7829500A07 Catalog Number : 9500

Device Description : Cell suspension containing fixed human lymphoblastoid REH (TdT+) and RA-1 (TdT-) 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

Device Class : 1

Duns Number: 071245690

Premarket Exempt : Yes

Product Code : KIR

Prescription Use : No

Device Count : 1

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