Genemed®

FDA UDI

Class I (US FDA UDI)

by Sakura Finetek USA, Inc

Identity

Trade Name: Genemed® FDA UDI
Generic Name: Thyroglobulin IVD, antibody FDA UDI
Device Name: anti-Thyroglobulin Mouse Monoclonal Antibody [2H11/6E1], Concentrate, 1 mL FDA UDI
Model / Reference: 61-0064 FDA UDI
Description: anti-Thyroglobulin Mouse Monoclonal Antibody [2H11/6E1], Concentrate, 1 mL FDA UDI

Identifiers

Catalog Number: 61-0064 FDA UDI
Primary DI / UDI-DI: 00615233004390 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Thyroglobulin 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: Thyroglobulin 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 Thyroglobulin IVD, antibody.

ANTI-THYROGLOBULIN — Biogenex Laboratories, Inc. · Class I
FLEX Poly Rb A-Hu Thyroglobulin RTU (Link) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
Thyroglobulin Control Slides — BIO SB, INC. · Class I
Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Mouse Monoclonal Anti-Human Thyroglobulin(MX131) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Rabbit Monoclonal Anti-Human Thyroglobulin Antibody, EP250 — EPITOMICS, INC. · Class I
Tinto Thyroglobulin, RMab — BIO SB, INC. · Class I
Thyroglobulin Cocktail — BIOCARE MEDICAL, LLC · 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 b85d31ff-875a-4e2d-ba55-0ad7ec2c92a4 35 fields · synced May 30, 2026