Identity
- Trade Name
- Urine Calibrator Set FDA UDI
- Generic Name
- Multiple amino acid IVD, calibrator FDA UDI
- Device Name
- 3PLUS1® Multilevel Urine Calibrator Set MassChrom® Amino Acid Analysis in urine FDA UDI
- Model / Reference
- 75228 FDA UDI
- Description
- 3PLUS1® Multilevel Urine Calibrator Set MassChrom® Amino Acid Analysis in urine FDA UDI
Identifiers
- Catalog Number
- 75228 FDA UDI
- Primary DI / UDI-DI
- 04250317551115 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Multiple amino acid 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 — 0.5 Milliliter FDA UDI
Category: Multiple amino acid IVD, calibrator
Urine Calibrator Set by Chromsystems Instruments & Chemicals GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple amino acid IVD, calibrator.
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 80b214bf-af57-44b0-9c98-1b48e18f64e0 37 fields · synced May 29, 2026