← Back to catalogue

Anti-IgG, -C3d (Polyspecific) (Murine Monoclonal) (Uncolored) Gamma-clone

FDA UDI

by Immucor, Inc.

Identity

Trade Name
Anti-IgG,-C3d (Polyspecific) (Murine Monoclonal) (Uncolored) Gamma-clone FDA UDI
Generic Name
Monospecific anti-complement component C3d (anti-C3d) IVD, antibody FDA UDI
Device Name
This product is used in direct or indirect antiglobulin tests where the detection of IgG or C3 (as C3b or C3d) is required. This product contains a blend of murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG, anti-C3d and anti-C3b. The package configuration for this product code is ten (10) vials of reagent. The color of the liquid reagent is clear. FDA UDI
Model / Reference
0401010 FDA UDI
Description
This product is used in direct or indirect antiglobulin tests where the detection of IgG or C3 (as C3b or C3d) is required. This product contains a blend of murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG, anti-C3d and anti-C3b. The package configuration for this product code is ten (10) vials of reagent. The color of the liquid reagent is clear. FDA UDI

Identifiers

Catalog Number
0401010 FDA UDI
Primary DI / UDI-DI
10888234001638 FDA UDI
GMDN Term
Monospecific anti-complement component C3d (anti-C3d) IVD, antibody FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Monospecific anti-complement component C3d (anti-C3d) IVD, antibody

Anti-IgG, -C3d (Polyspecific) (Murine Monoclonal) (Uncolored) Gamma-clone by Immucor, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Monospecific anti-complement component C3d (anti-C3d) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Immucor, Inc.

Sources (1)

  • FDA UDI 15b02546-f7ff-4187-bf63-6cf1bb423c4f 35 fields · synced May 31, 2026