Genemed®

FDA UDI

Class I (US FDA UDI)

by Sakura Finetek USA, Inc

Identity

Trade Name: Genemed® FDA UDI
Generic Name: Chromogranin A IVD, antibody FDA UDI
Device Name: anti-Chromogranin A Rabbit Polyclonal Antibody, Concentrate, 1 mL FDA UDI
Model / Reference: 61-0015 FDA UDI
Description: anti-Chromogranin A Rabbit Polyclonal Antibody, Concentrate, 1 mL FDA UDI

Identifiers

Catalog Number: 61-0015 FDA UDI
Primary DI / UDI-DI: 00615233005199 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Chromogranin A 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: Chromogranin A 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 Chromogranin A IVD, antibody.

Q-STAIN® QSX-Enh-F CgA — NOVODIAX, INC. · Class I
Novocastra — Leica Biosystems Newcastle, Limited · Class I
ANTI-CHROMOGRANIN A — Biogenex Laboratories, Inc. · Class I
Anti-Chromogranin A (LK2H10) Primary Antibody — Ventana Medical Systems · Class I
ANTI-CHROMOGRANIN A — Biogenex Laboratories, Inc. · Class I
Chromogranin A (LK2H10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Rabbit Monoclonal Anti-Human Chromogranin A Antibody, EP38 — EPITOMICS, INC. · Class I
BOND™ — Leica Biosystems Newcastle, Limited · 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

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Manufacturer

Manufacturer: Sakura Finetek USA, Inc

Sources (1)

FDA UDI ea1261d0-6207-415c-a36e-458d2461565d 35 fields · synced Jun 1, 2026