FDA UDI
In Commercial Distribution
🇺🇸 United States
Salivary Estradiol HS ELISA
DI: 00840239061454
·
Model: SLV-6145
·
DRG International Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Salivary Estradiol HS ELISA
- Primary DI
- 00840239061454
- Version / Model
- SLV-6145
- Catalog Number
- SLV-6145
- Company Name
- DRG International Inc
- Labeler DUNS
- 075150847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-26
- Public Version
- 1
- Public Version Date
- 2023-09-04
- Public Version Status
- New
- Public Device Record Key
- abb1cbaf-3ea3-464d-a743-4972e92fd5f1
Device Description
The DRG Salivary Estradiol HS ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free estradiol in saliva. Results may be used to assess fertility problems in women; to diagnose menopause, and to monitor hormone replacement therapy.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| CHP | Radioimmunoassay, Estradiol | Clinical Chemistry | 862.1260 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54152 | Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) 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 | 00840239061454 | GS1 |
Customer Contacts
- Phone
- 1 973-564-7555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius