Identity
- Trade Name
- CalCheck Phospho-Tau (181P) FDA UDI
- Generic Name
- Tau protein IVD, control FDA UDI
- Model / Reference
- 07546424190 FDA UDI
Identifiers
- Catalog Number
- 07546424190 FDA UDI
- Primary DI / UDI-DI
- 07613336208373 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Tau protein IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tau protein IVD, control
CalCheck Phospho-Tau (181P) by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 5882084a-d30e-45d0-ab0c-b0f24c35ce24 33 fields · synced May 31, 2026