FDA UDI
In Commercial Distribution
🇺🇸 United States
Salimetrics
DI: 00859410006146
·
Model: N/A
·
SALIMETRICS, LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Salimetrics
- Primary DI
- 00859410006146
- Version / Model
- N/A
- Catalog Number
- 1-2212
- Company Name
- SALIMETRICS, LLC
- Labeler DUNS
- 084843064
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-23
- Public Version
- 1
- Public Version Date
- 2022-08-31
- Public Version Status
- New
- Public Device Record Key
- aa3f588f-7fb9-41e0-bec9-4079afe302c6
Device Description
Salivary DHEA Enzyme Immunoassay Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54137 | Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of dehydroepiandrosterone (DHEA) 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 | 00859410006146 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius