CA-125 RMab

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: CA-125 RMab FDA UDI
Generic Name: Cancer antigen 125 (CA125) IVD, antibody FDA UDI
Device Name: CA-125 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, 0.5 ml FDA UDI
Description: CA-125 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 6405 FDA UDI
Primary DI / UDI-DI: B502BSB64050 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Cancer antigen 125 (CA125) 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: Cancer antigen 125 (CA125) IVD, antibody

CA-125 RMab by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cancer antigen 125 (CA125) IVD, antibody.

ANTI-CA125 — Biogenex Laboratories, Inc. · Class I
Rabbit Monoclonal Anti-Human CA 125 Antibody, EP48 — EPITOMICS, INC. · Class I
FLEX Mono Mo A-Hu CA 125 Cl M11 RTU (Link) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
FLEX Mono Mo A-Hu CA 125 Cl M11 RTU — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
Novocastra — Leica Biosystems Newcastle, Limited · Class I
CA-125 (OC125) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
CA-125 (OC125) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
CA 125 — 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: Bio Sb, Inc.

Sources (1)

FDA UDI 97853358-48e4-4b80-b69d-8d025ae900cb 34 fields · synced May 30, 2026