Identity
- Trade Name
- Plasma Control FDA UDI
- Generic Name
- Multiple-therapy therapeutic drug monitoring IVD, control FDA UDI
- Device Name
- Plasma Control Level I, Imatinib, Dasatinib, Nilotinib FDA UDI
- Model / Reference
- 0225 FDA UDI
- Description
- Plasma Control Level I, Imatinib, Dasatinib, Nilotinib FDA UDI
Identifiers
- Catalog Number
- 0225 FDA UDI
- Primary DI / UDI-DI
- 04250317544544 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Multiple-therapy therapeutic drug monitoring IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple-therapy therapeutic drug monitoring IVD, control
Unlock the power of Plasma Control, a cutting-edge Level I Imatinib, Dasatinib, Nilotinib device designed for precise and accurate drug therapy monitoring in clinical settings. With its advanced features and robust design, Plasma Control ensures reliable performance and helps healthcare professionals deliver high-quality patient care.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Chromsystems Instruments & Chemicals GmbH
Sources (1)
- FDA UDI c4debc0b-7da8-40f4-8e54-f3a67d65d948 37 fields · synced Jul 3, 2026