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IgE, Polyclonal, RPab

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref BSB 3070

by Bio SB Inc

Identity

Trade Name
IgE, Polyclonal, RPab EUDAMED
IgE, RPab FDA UDI
Generic Name
Total immunoglobulin E (IgE total) IVD, antibody FDA UDI
Device Name
IgE, Polyclonal, RPab EUDAMED
IgE is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5. FDA UDI
Model / Reference
BSB 3070 EUDAMED
Concentrate, 0.1 ml FDA UDI
Description
IgE is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5. FDA UDI

Identifiers

Catalog Number
BSB 3070 FDA UDI
Primary DI / UDI-DI
B502BSB30700 EUDAMEDFDA UDI
Basic UDI-DI
B-B502BSB30700 EUDAMED
FDA Product Code
NJT FDA UDI
EMDN Code
W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
GMDN Term
Total immunoglobulin E (IgE total) 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

IgE, Polyclonal, RPab 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

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Manufacturer

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

Sources (2)

  • EUDAMED fd06f2ba-6218-4a5a-8dea-8a5becae2f30 61 fields · synced Jul 13, 2026
  • FDA UDI 491966bf-37bd-49ad-a10e-21670736d88f 34 fields · synced May 30, 2026