FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Vitamin D 200 Series
DI: 00842365100182
·
Model: 5044490
·
AB Sciex
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vitamin D 200 Series
- Primary DI
- 00842365100182
- Version / Model
- 5044490
- Company Name
- AB Sciex
- Labeler DUNS
- 079640773
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-07
- Public Version
- 4
- Public Version Date
- 2020-08-11
- Public Version Status
- Update
- Public Device Record Key
- c39962a1-926c-4377-aed0-2393a428f3f1
- Distribution End Date
- 2020-07-23
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| PSL | 25-Oh-Vitamin D Mass Spectrometry Test System | Clinical Chemistry | 862.1840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62018 | Multiple form 25-hydroxy Vitamin D IVD, kit, liquid chromatography/mass spectrometry (LC/MS) | 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 a liquid chromatography/mass spectrometry (LC/MS) method. It is used in the investigation of conditions associated with vitamin D deficiency and for the assessment of vitamin D status during supplementation therapy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842365100182 | GS1 |