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Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL FDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, control FDA UDI
- Device Name
- The Complete D 25-OH Vitamin D control is intended to monitor the performance of clinical assays used to quantitate total 25-OH Vitamin D. It is supplied in two levels, 3mL per vial. Each kit contains 2 vials of level 1 and 2 vials of level 2 controls. The controls are liquid, ready to use and require no reconstitution of dilution. The controls are prepared in a human serum matrix fortified with analytes and preservatives. This control contains both 25-OH Vitamin D2 and D3, and when combined represent clinically relevant levels of Total Vitamin D. FDA UDI
- Model / Reference
- 1290-01 FDA UDI
- Description
- The Complete D 25-OH Vitamin D control is intended to monitor the performance of clinical assays used to quantitate total 25-OH Vitamin D. It is supplied in two levels, 3mL per vial. Each kit contains 2 vials of level 1 and 2 vials of level 2 controls. The controls are liquid, ready to use and require no reconstitution of dilution. The controls are prepared in a human serum matrix fortified with analytes and preservatives. This control contains both 25-OH Vitamin D2 and D3, and when combined represent clinically relevant levels of Total Vitamin D. FDA UDI
Identifiers
- Catalog Number
- 1290-01 FDA UDI
- Primary DI / UDI-DI
- 00896863002059 FDA UDI
- 510(k) Number
- K113177 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Multiple form 25-hydroxy Vitamin D IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple form 25-hydroxy Vitamin D IVD, control
Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL by Quantimetrix Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple form 25-hydroxy Vitamin D IVD, control.
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- BioPlex 2200 — Bio-Rad Laboratories · Class I
- Method Verification Kit - Vitamin D — QUALIGEN INC. · Class I
- Atellica IM VitD MCM — Siemens Healthcare Diagnostics · Class I
- Diazyme — Diazyme Laboratories, Inc.
- Alinity — ABBOTT IRELAND · Class I
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 |
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Manufacturer
- Manufacturer
- Quantimetrix Corp.
Sources (1)
- FDA UDI af0feafe-ccc4-45f5-95e0-5c2414c2ecff 37 fields · synced Jun 1, 2026