Identity
- Trade Name
- Gamma PeG FDA UDI
- Generic Name
- Polyethylene glycol (PEG) immunohaematology reagent IVD FDA UDI
- Device Name
- Gamma PeG is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Polyethylene Glycol (PeG) in a low ionic strength saline solution, and is the ten (10) vial configuration. FDA UDI
- Model / Reference
- 0705010 FDA UDI
- Description
- Gamma PeG is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Polyethylene Glycol (PeG) in a low ionic strength saline solution, and is the ten (10) vial configuration. FDA UDI
Identifiers
- Catalog Number
- 0705010 FDA UDI
- Primary DI / UDI-DI
- 10888234001799 FDA UDI
- FDA Product Code
- KSG FDA UDI
- GMDN Term
- Polyethylene glycol (PEG) immunohaematology reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9600 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
Yes
FDA UDI
Prescription Use
Yes
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
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: Polyethylene glycol (PEG) immunohaematology reagent IVD
Gamma PeG by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene glycol (PEG) immunohaematology reagent IVD.
- PEG — AMERICAN NATIONAL RED CROSS · Class II
- BioReady — Nanocomposix, LLC · Class I
- ALBAhance PEG — ALBA BIOSCIENCE LIMITED · Class II
- Gamma PeG — IMMUCOR, INC. · Class II
Cleared under the same submission
BK910001 also covers:
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI e4c65f1a-10ac-4ad8-b1fb-70f73328d5da 37 fields · synced May 31, 2026