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FITC TdT Negative Control IgG1

FDA UDI

Class I (US FDA UDI)

by Supertechs, Inc.

Identity

Trade Name
FITC TdT Negative Control IgG1 FDA UDI
Generic Name
Terminal deoxynucleotidyl transferase (TdT) IVD, control FDA UDI
Device Name
Analyte Specific Reagent FITC conjugated mouse IgG1 negative control 0.5 mL vial for approximately 50 tests FDA UDI
Model / Reference
8100A FDA UDI
Description
Analyte Specific Reagent FITC conjugated mouse IgG1 negative control 0.5 mL vial for approximately 50 tests FDA UDI

Identifiers

Catalog Number
8100 FDA UDI
Primary DI / UDI-DI
B7828100A02 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Terminal deoxynucleotidyl transferase (TdT) IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Terminal deoxynucleotidyl transferase (TdT) IVD, control

FITC TdT Negative Control IgG1 by Supertechs, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Terminal deoxynucleotidyl transferase (TdT) IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Supertechs, Inc.

Sources (1)

  • FDA UDI dfc5d4a7-6cac-4d68-a388-aaf4acfac51e 35 fields · synced May 30, 2026