Identity
- Trade Name
- Serum Calibrator Set FDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, calibrator FDA UDI
- Device Name
- 6PLUS1® Multilevel Serum Calibrator Set MassChrom® 25-OH-Vitamin D3/D2 in serum/plasma FDA UDI
- Model / Reference
- 62039/CUSTOM/MAYO FDA UDI
- Description
- 6PLUS1® Multilevel Serum Calibrator Set MassChrom® 25-OH-Vitamin D3/D2 in serum/plasma FDA UDI
Identifiers
- Catalog Number
- 62039/CUSTOM/MAYO FDA UDI
- Primary DI / UDI-DI
- 04250317551511 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Multiple form 25-hydroxy Vitamin D 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 — 5 Milliliter FDA UDI
Category: Multiple form 25-hydroxy Vitamin D IVD, calibrator
Serum Calibrator Set by Chromsystems Instruments & Chemicals GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Diazyme — Diazyme Laboratories, Inc.
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- IDS-iSYS 25-Hydroxy Vitamin DS Calibration Verifiers — Immunodiagnostic Systems , Ltd. · Class I
- Diazyme — Diazyme Laboratories, Inc.
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 3cee8816-e12d-4ec3-93f5-7362eefa67ac 37 fields · synced May 30, 2026