Cytokeratin 13 RMab

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: Cytokeratin 13 RMab FDA UDI
Generic Name: Cytokeratin IVD, antibody FDA UDI
Device Name: Anti-Cytokeratin 13 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: Concentrate, 0.1 ml FDA UDI
Description: Anti-Cytokeratin 13 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 6677 FDA UDI
Primary DI / UDI-DI: B502BSB66770 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Cytokeratin 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: Cytokeratin IVD, antibody

Cytokeratin 13 RMab by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cytokeratin IVD, antibody.

ANTI-CYTOKERATIN PAN — Biogenex Laboratories, Inc. · Class I
Rabbit Monoclonal Anti-Human Cytokeratin 13 Antibody, EP69 — EPITOMICS, INC. · Class I
Mouse Monoclonal Anti-Human CK-HMW(MX134) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Novocastra™ — Leica Biosystems Newcastle, Limited · Class I
Rabbit Monoclonal Anti-Human Cytokeratin 19 Antibody, EP72 — EPITOMICS, INC. · Class I
Rabbit Monoclonal Anti-Human Cytokeratin 5 Antibody, EP42 — EPITOMICS, INC. · Class I
Mono Mo A-Hu Cytokeratin 10/13 Cl DE-K13 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
Cytokeratin (CAM 5.2) 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

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Manufacturer

Manufacturer: Bio Sb, Inc.

Sources (1)

FDA UDI 707967e3-fe7f-4f68-ba1b-c538e22996ff 34 fields · synced May 30, 2026