Identity
- Trade Name
- Refractix™ DSP FDA UDI
- Generic Name
- Clinical specimen refractometer FDA UDI
- Model / Reference
- 13930000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812559012522 FDA UDI
- FDA Product Code
- PSM FDA UDI
- GMDN Term
- Clinical specimen refractometer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2800 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Clinical specimen refractometer
Refractix™ DSP by Reichert Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Clinical specimen refractometer.
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
- Reichert Inc.
Sources (1)
- FDA UDI 9bebef21-6e6a-4a31-9d19-283e94917963 33 fields · synced May 30, 2026