Identity
- Trade Name
- ORTHO FDA UDI
- Generic Name
- Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody FDA UDI
- Device Name
- ANTI-IGG 100X10ML FDA UDI
- Model / Reference
- 716300 FDA UDI
- Description
- ANTI-IGG 100X10ML FDA UDI
Identifiers
- Catalog Number
- 716300 FDA UDI
- Primary DI / UDI-DI
- 10758750003549 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
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
Ortho by Ortho-Clinical Diagnostics — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI 6c42dd5b-c838-4638-a7c9-36a6a16c55b4 35 fields · synced May 31, 2026