← Back to catalogue

hCG, BSB-38, MMab

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref BSB 5601

by Bio SB Inc

Identity

Trade Name
hCG, BSB-38, MMab EUDAMED
hCG MMab FDA UDI
Generic Name
Total human chorionic gonadotropin IVD, antibody FDA UDI
Device Name
hCG, BSB-38, MMab EUDAMED
hCG is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
Model / Reference
BSB 5601 EUDAMED
Concentrate, 1 ml FDA UDI
Description
hCG is a mouse 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 5601 FDA UDI
Primary DI / UDI-DI
B502BSB56010 EUDAMEDFDA UDI
Basic UDI-DI
B-B502BSB56010 EUDAMED
FDA Product Code
NJT FDA UDI
EMDN Code
W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
GMDN Term
Total human chorionic gonadotropin IVD, antibody FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
864.1860 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

hCG, BSB-38, MMab by Bio Sb, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bio SB Inc
EUDAMED SRN
US-MF-000036462
Authorised Representative
QAdvis EAR AB SE-AR-000001599

Sources (2)

  • EUDAMED 54f2abb3-ba12-4746-a147-6c7af3594604 61 fields · synced Aug 2, 2026
  • FDA UDI f08717b8-3075-482f-9587-1f56a4c2e738 34 fields · synced May 30, 2026