FDA UDI
In Commercial Distribution
🇺🇸 United States
25OH Vitamin D Total ELISA
DI: B2423825DHUE010
·
Model: 38-25DHU-E01
·
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 25OH Vitamin D Total ELISA
- Primary DI
- B2423825DHUE010
- Version / Model
- 38-25DHU-E01
- Catalog Number
- 38-25DHU-E01
- Company Name
- AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
- Labeler DUNS
- 784143778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-18
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 779e2f80-6930-444a-bcb1-5957e2158f36
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRG | System, Test, Vitamin D | Clinical Chemistry | 862.1825 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58942 | Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy Vitamin D in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B2423825DHUE010 | HIBCC |
Customer Contacts
- Phone
- 800.592.5726
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123364 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius