Identity
- Trade Name
- 25OH Vitamin D Total ELISA FDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The 25OH Vitamin D Total ELISA Test is intended for the quantitative determination of 25-hydroxyvitamin D2 and D3 (25-OH D2 and 25-OH D3) in human serum. The results are to be used in conjunction with other clinical and laboratory findings to assess the Vitamin D status of a patient. FDA UDI
- Model / Reference
- 38-25DHU-E01 FDA UDI
- Description
- The 25OH Vitamin D Total ELISA Test is intended for the quantitative determination of 25-hydroxyvitamin D2 and D3 (25-OH D2 and 25-OH D3) in human serum. The results are to be used in conjunction with other clinical and laboratory findings to assess the Vitamin D status of a patient. FDA UDI
Identifiers
- Catalog Number
- 38-25DHU-E01 FDA UDI
- Primary DI / UDI-DI
- B2423825DHUE010 FDA UDI
- 510(k) Number
- K123364 FDA UDI
- FDA Product Code
- MRG FDA UDI
- GMDN Term
- Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA) 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
Yes
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, kit, enzyme immunoassay (EIA)
25OH Vitamin D Total ELISA by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- American Laboratory Products Company
Sources (1)
- FDA UDI 779e2f80-6930-444a-bcb1-5957e2158f36 37 fields · synced Jun 7, 2026