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ClearChem Diagnostics Inc. Vitamin D (25-OH-D) Set
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ClearChem Diagnostics Inc. Vitamin D (25-OH-D) Set FDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, reagent FDA UDI
- Device Name
- In Vitro Diagnostics testing set R1: 1X40mL, R2: 1X10mL FDA UDI
- Model / Reference
- VTD1200 FDA UDI
- Description
- In Vitro Diagnostics testing set R1: 1X40mL, R2: 1X10mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852169008386 FDA UDI
- FDA Product Code
- MRG FDA UDI
- GMDN Term
- Multiple form 25-hydroxy Vitamin D IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1825 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 50 Milliliter FDA UDI
Category: Multiple form 25-hydroxy Vitamin D IVD, reagent
ClearChem Diagnostics Inc. Vitamin D (25-OH-D) Set by Clearchem Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple form 25-hydroxy Vitamin D IVD, reagent.
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- IDS-iSYS 25-Hydroxy Vitamin DS — Immunodiagnostic Systems , Ltd. · Class II
- 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
- Clearchem Diagnostics Inc.
Sources (1)
- FDA UDI e7c436c6-a60d-4d9f-ae68-d13e48bcba97 36 fields · synced May 30, 2026