Identity
- Trade Name
- BioReady FDA UDI
- Generic Name
- Polyethylene glycol (PEG) immunohaematology reagent IVD FDA UDI
- Device Name
- BioReady, 150nm Carboxyl Gold Nanoshells FDA UDI
- Model / Reference
- 150nm Carboxyl Gold Nanoshells FDA UDI
- Description
- BioReady, 150nm Carboxyl Gold Nanoshells FDA UDI
Identifiers
- Catalog Number
- 80-1020 FDA UDI
- Primary DI / UDI-DI
- 00860010517604 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Polyethylene glycol (PEG) immunohaematology reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Category: Polyethylene glycol (PEG) immunohaematology reagent IVD
BioReady by Nanocomposix, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene glycol (PEG) immunohaematology reagent IVD.
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- ALBAhance PEG — ALBA BIOSCIENCE LIMITED · Class II
- Gamma PeG — IMMUCOR, INC. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Nanocomposix, LLC
Sources (1)
- FDA UDI e2fd0e07-a20f-408a-9219-28ba35cde6ee 36 fields · synced Jun 6, 2026