Genemed®

FDA UDI

Class I (US FDA UDI)

by Sakura Finetek USA, Inc

Identity

Trade Name: Genemed® FDA UDI
Generic Name: Bcl-2 oncoprotein IVD, antibody FDA UDI
Device Name: anti-Bcl-2 Mouse Monoclonal Antibody [Bcl-2-100], Concentrate, 1 mL FDA UDI
Model / Reference: 61-0005 FDA UDI
Description: anti-Bcl-2 Mouse Monoclonal Antibody [Bcl-2-100], Concentrate, 1 mL FDA UDI

Identifiers

Catalog Number: 61-0005 FDA UDI
Primary DI / UDI-DI: 00615233005809 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Bcl-2 oncoprotein 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bcl-2 oncoprotein 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 Bcl-2 oncoprotein IVD, antibody.

BCL2 (124) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
BCL2 (E17) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
BCL2 (SP66) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Human Bcl-2 R-PE Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
Confirm anti-Cytokeratin 7 (SP52) Rabbit Monoclonal Primary Antibody — Ventana Medical Systems · Class I
ANTI-BCL-2 ONCOPROTEIN — Biogenex Laboratories, Inc. · Class I
Bcl-2 — BIOCARE MEDICAL, LLC · Class I
BCL2 (124) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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

Manufacturer

Manufacturer: Sakura Finetek USA, Inc

Sources (1)

FDA UDI f2eff0c0-7838-4811-921a-a27e6712d817 35 fields · synced Jun 6, 2026