← Back to catalogue

Genemed®

FDA UDI

Class I (US FDA UDI)

by Sakura Finetek USA, Inc

Identity

Trade Name
Genemed® FDA UDI
Generic Name
Thyroid transcription factor-1 (TTF1) IVD, antibody FDA UDI
Device Name
anti-TTF-1 Mouse Monoclonal Antibody [8G7G3/1], Concentrate, 1 mL FDA UDI
Model / Reference
61-0065 FDA UDI
Description
anti-TTF-1 Mouse Monoclonal Antibody [8G7G3/1], Concentrate, 1 mL FDA UDI

Identifiers

Catalog Number
61-0065 FDA UDI
Primary DI / UDI-DI
00615233004369 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Thyroid transcription factor-1 (TTF1) IVD, antibody FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.1860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Category: Thyroid transcription factor-1 (TTF1) IVD, antibody

Genemed® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thyroid transcription factor-1 (TTF1) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sakura Finetek USA, Inc

Sources (1)

  • FDA UDI b60cff77-65e5-49c3-99a4-88efde0b2fb7 35 fields · synced May 31, 2026