Tinto Thyroglobulin, RMab

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: Tinto Thyroglobulin, RMab FDA UDI
Generic Name: Thyroglobulin IVD, antibody FDA UDI
Device Name: Tinto Thyroglobulin is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
Model / Reference: Predilute, 3 ml FDA UDI
Description: Tinto Thyroglobulin is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI

Identifiers

Catalog Number: BSB 2363 FDA UDI
Primary DI / UDI-DI: B502BSB23630 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Thyroglobulin IVD, antibody

Tinto Thyroglobulin, RMab by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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
Thyroglobulin Cocktail — BIOCARE MEDICAL, LLC · Class I
Mouse Monoclonal Anti-Human Thyroglobulin(MX131) Antibody — Fuzhou Maixin Biotech Co., Ltd. · 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: Bio Sb, Inc.

Sources (1)

FDA UDI 5cc72e01-be4c-4431-afc1-2705702de9e7 34 fields · synced May 30, 2026