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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
Cancer antigen 19-9 (CA19-9) GI IVD, antibody FDA UDI
Device Name
anti-CA19-9 (Sialyl Lewis) Mouse Monoclonal Antibody [SPan-1], Concentrate, 1 mL FDA UDI
Model / Reference
61-0142 FDA UDI
Description
anti-CA19-9 (Sialyl Lewis) Mouse Monoclonal Antibody [SPan-1], Concentrate, 1 mL FDA UDI

Identifiers

Catalog Number
61-0142 FDA UDI
Primary DI / UDI-DI
00615233003638 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Cancer antigen 19-9 (CA19-9) GI 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: Cancer antigen 19-9 (CA19-9) GI 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 Cancer antigen 19-9 (CA19-9) GI 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 08b134b3-824e-4a6f-953b-558e59607462 35 fields · synced May 30, 2026