Identity
- Trade Name
- BioReady FDA UDI
- Generic Name
- Citrate staining/testing reagent IVD FDA UDI
- Device Name
- BioReady 40nm Gold Citrate Nanospheres FDA UDI
- Model / Reference
- 40nm Gold Citrate Nanospheres FDA UDI
- Description
- BioReady 40nm Gold Citrate Nanospheres FDA UDI
Identifiers
- Catalog Number
- 80-1018 FDA UDI
- Primary DI / UDI-DI
- 00860010517628 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Citrate staining/testing 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: Citrate staining/testing reagent IVD
BioReady by Nanocomposix, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 0775c107-53de-415f-8832-edbd6c7c9f65 36 fields · synced May 30, 2026