Identity
- Trade Name
- FREND Testosterone FDA UDI
- Generic Name
- Total testosterone IVD, reagent FDA UDI
- Device Name
- It is used for the quantitiative determination of Testosterone in human specimen using FREND System. FDA UDI
- Model / Reference
- FRTE-HB FDA UDI
- Description
- It is used for the quantitiative determination of Testosterone in human specimen using FREND System. FDA UDI
Identifiers
- Catalog Number
- FRTE 020 FDA UDI
- Primary DI / UDI-DI
- 08809317540153 FDA UDI
- 510(k) Number
- K153577 FDA UDI
- FDA Product Code
- CDZ FDA UDI
- GMDN Term
- Total testosterone IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1680 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
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: Total testosterone IVD, reagent
FREND Testosterone by NanoEnTek, Inc. — 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
- NanoEnTek, Inc.
Sources (1)
- FDA UDI d6b7ead6-f9d6-4230-b262-b62ad121685c 35 fields · synced Jun 1, 2026