Identity
- Trade Name
- CSAII Cyclosporine II FDA UDI
- Generic Name
- Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassay FDA UDI
- Model / Reference
- 4340892190 FDA UDI
Identifiers
- Catalog Number
- 4340892190 FDA UDI
- Primary DI / UDI-DI
- 04015630997459 FDA UDI
- PMA Number
- P920031 FDA UDI
- FDA Product Code
- MKW FDA UDI
- GMDN Term
- Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1235 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
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: Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassay
CSAII Cyclosporine II by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassay.
- CEDIA Cyclosporine-PLUS Assay — Microgenics Corporation · Class II
Cleared under the same submission
P920031 also covers:
- Cyclosporine Calibrator 0 ng/mL — Roche Diagnostics Corp.
- Cyclosporine Calibrators — Roche Diagnostics Corp.
- Syva® Emit® 2000 Cyclosporine Specific Calibrators — Siemens Healthcare Diagnostics
- Syva® Emit® 2000 Cyclosporine Specific Negative Calibrator — Siemens Healthcare Diagnostics
- Syva® Emit® Cyclosporine Pretreatment Reagent — Siemens Healthcare Diagnostics
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 6ac3dedb-06b5-42c5-ba8a-a4f792fe0143 35 fields · synced May 30, 2026