Identity
- Trade Name
- Augurex Life Sciences FDA UDI
- Generic Name
- Protein 14-3-3 IVD, reagent FDA UDI
- Device Name
- Anti-Human 14-3-3eta mAb, 37F8 ASR FDA UDI
- Model / Reference
- 90-0009 FDA UDI
- Description
- Anti-Human 14-3-3eta mAb, 37F8 ASR FDA UDI
Identifiers
- Catalog Number
- 90-0009 FDA UDI
- Primary DI / UDI-DI
- 06284510990417 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Protein 14-3-3 IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Augurex Life Sciences by Cedarlane Corporation — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cedarlane Corporation
Sources (1)
- FDA UDI 8322c3b2-f6f5-4308-bd77-22ec67ef4947 37 fields · synced May 30, 2026