Identity
- Trade Name
- C.f.a.s. Cystatin C FDA UDI
- Generic Name
- Cystatin C IVD, calibrator FDA UDI
- Model / Reference
- 4975901191 FDA UDI
Identifiers
- Catalog Number
- 4975901191 FDA UDI
- Primary DI / UDI-DI
- 04015630934973 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Cystatin C IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
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
No
FDA UDI
Category: Cystatin C IVD, calibrator
C.f.a.s. Cystatin C by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cystatin C IVD, calibrator.
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- Diazyme — Diazyme Laboratories, Inc.
- Dako — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- ADVIA Cystatin C_2 Calibrator — Siemens Healthcare Diagnostics · Class II
- CYSC CAL — Randox Laboratories, Ltd. · Class II
- Cystatin C Calibrators — Sentinel Ch. Srl · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 6fc5b64c-016e-4fee-86ae-9ad54ffb85a6 33 fields · synced May 29, 2026