Identity
- Trade Name
- Plasma Calibrator Set FDA UDI
- Generic Name
- Multiple-therapy therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- 3PLUS1® Multilevel Plasma Calibrator Set Antibiotics FDA UDI
- Model / Reference
- 61028 FDA UDI
- Description
- 3PLUS1® Multilevel Plasma Calibrator Set Antibiotics FDA UDI
Identifiers
- Catalog Number
- 61028 FDA UDI
- Primary DI / UDI-DI
- 04250317541765 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Multiple-therapy therapeutic drug monitoring 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
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
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Multiple-therapy therapeutic drug monitoring IVD, calibrator
Plasma Calibrator Set by Chromsystems Instruments & Chemicals GmbH — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Chromsystems Instruments & Chemicals GmbH
Sources (1)
- FDA UDI 5d25ddf1-4626-4259-b77f-8157795d75ec 37 fields · synced May 30, 2026