Identity
- Trade Name
- Anti-IgG (Murine Monoclonal) (Green) Gamma-clone FDA UDI
- Generic Name
- Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody FDA UDI
- Device Name
- This product is used in direct or indirect antiglobulin tests where the detection of IgG is required. This product contains a murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG. The package configuration for this product code is ten (10) vials of reagent. The color of the liquid reagent is green. FDA UDI
- Model / Reference
- 0409210 FDA UDI
- Description
- This product is used in direct or indirect antiglobulin tests where the detection of IgG is required. This product contains a murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG. The package configuration for this product code is ten (10) vials of reagent. The color of the liquid reagent is green. FDA UDI
Identifiers
- Catalog Number
- 0409210 FDA UDI
- Primary DI / UDI-DI
- 10888234001669 FDA UDI
- GMDN Term
- Monospecific immunoglobulin G antihuman globulin (IgG AHG) 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 immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
Anti-IgG (Murine Monoclonal) (Green) Gamma-clone by Immucor, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody.
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- ORTHO — Ortho-Clinical Diagnostics
- Anti-Human Globulin Anti-IgG (Rabbit) (Green) — ALBA BIOSCIENCE LIMITED
- ORTHO — Ortho-Clinical Diagnostics
- ORTHO — Ortho-Clinical Diagnostics
- Anti-Human Globulin Anti-IgG — ALBA BIOSCIENCE LIMITED
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI fbf74c93-aa07-45f3-bab5-5881b6a4112b 35 fields · synced May 31, 2026