FITC TdT Reagent - Analyte Specific ReagentFITC conjugated mouse - SUPERTECHS, INC

Duns Number:071245690

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

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More Product Details

Catalog Number

6100C

Brand Name

FITC TdT Reagent

Version/Model Number

6100C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MVU

Product Code Name

Reagents, Specific, Analyte

Device Record Status

Public Device Record Key

37dbc73c-6e41-4d52-b148-2d3aca9d4249

Public Version Date

October 16, 2019

Public Version Number

1

DI Record Publish Date

October 08, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUPERTECHS, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7