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Genemed®

FDA UDI

Class I (US FDA UDI)

by Sakura Finetek USA, Inc

Identity

Trade Name
Genemed® FDA UDI
Generic Name
MLH1 antigen IVD, antibody FDA UDI
Device Name
anti-MLH1 Mouse Monoclonal Antibody [GM011], Ready-To-Use, 7 mL FDA UDI
Model / Reference
60-0079-7 FDA UDI
Description
anti-MLH1 Mouse Monoclonal Antibody [GM011], Ready-To-Use, 7 mL FDA UDI

Identifiers

Catalog Number
60-0079-7 FDA UDI
Primary DI / UDI-DI
00615233006356 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
MLH1 antigen 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: MLH1 antigen 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 MLH1 antigen IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sakura Finetek USA, Inc

Sources (1)

  • FDA UDI 404203fa-4ea7-4f2f-b95a-1fda050491c7 35 fields · synced Jun 8, 2026