Identity
- Trade Name
- Plasma Control FDA UDI
- Generic Name
- Amiodarone IVD, control FDA UDI
- Device Name
- Plasma Control Level II, Amiodarone, Desethylamiodarone in serum/plasma FDA UDI
- Model / Reference
- 0068 FDA UDI
- Description
- Plasma Control Level II, Amiodarone, Desethylamiodarone in serum/plasma FDA UDI
Identifiers
- Catalog Number
- 0068 FDA UDI
- Primary DI / UDI-DI
- 04250317543899 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Amiodarone 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
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Amiodarone IVD, control
Plasma Control by Chromsystems Instruments & Chemicals GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amiodarone IVD, control.
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
- Chromsystems Instruments & Chemicals GmbH
Sources (1)
- FDA UDI 89046398-fcbb-4d09-aea0-4a8c5a94fc42 37 fields · synced May 30, 2026