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IgG4 (EP138) Rabbit Monoclonal Primary Antibody

FDA UDI

Class I (US FDA UDI)

by Cell Marque Corporation

Identity

Trade Name
IgG4 (EP138) Rabbit Monoclonal Primary Antibody FDA UDI
Generic Name
Immunoglobulin G subclass (IgG subclass) IVD, antibody FDA UDI
Model / Reference
367R-17 FDA UDI

Identifiers

Primary DI / UDI-DI
00841683111979 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Immunoglobulin G subclass (IgG subclass) 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Immunoglobulin G subclass (IgG subclass) IVD, antibody

IgG4 (EP138) Rabbit Monoclonal Primary Antibody by Cell Marque Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Immunoglobulin G subclass (IgG subclass) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cell Marque Corporation

Sources (1)

  • FDA UDI c1f27d42-9143-42da-9c21-8243ace3551f 33 fields · synced May 31, 2026