Tinto Beta-Catenin, RMab

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: Tinto Beta-Catenin, RMab FDA UDI
Generic Name: Beta-catenin IVD, antibody FDA UDI
Device Name: Tinto Beta-Catenin 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, 15 ml FDA UDI
Description: Tinto Beta-Catenin 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 2044 FDA UDI
Primary DI / UDI-DI: B502BSB20440 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Beta-catenin 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: Beta-catenin IVD, antibody

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

Similar devices

Also classified as Beta-catenin IVD, antibody.

Rabbit Monoclonal Anti-Human Beta-Catenin(MXR022) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Beta-Catenin (14) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Beta-Catenin — BIOCARE MEDICAL, LLC · Class I
Novocastra — Leica Biosystems Newcastle, Limited · Class I
FLEX Mono Mo A-Hu Beta-Catenin Cl ß-Catenin-1 RTU (Dako Omnis) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
Rabbit Monoclonal Anti-Human Beta-Catenin(MXR022) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Beta-Catenin (14) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Tissue-Tek Genie® — Sakura Finetek USA, Inc · 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 8e3ff4ea-b4b7-4bfd-b1c0-0afed9934194 34 fields · synced Jun 8, 2026