FDA UDI
In Commercial Distribution
🇺🇸 United States
Testosterone ELISA
DI: 00840239015594
·
Model: EIA-1559
·
DRG International Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Testosterone ELISA
- Primary DI
- 00840239015594
- Version / Model
- EIA-1559
- Catalog Number
- EIA-1559
- Company Name
- DRG International Inc
- Labeler DUNS
- 075150847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-23
- Public Version
- 1
- Public Version Date
- 2023-08-31
- Public Version Status
- New
- Public Device Record Key
- ed7927ff-8ead-4d71-9fa2-6606f8409e98
Device Description
The DRG Testosterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of testosterone in serum or plasma (EDTA, lithium heparin or citrate plasma).
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
- 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 |
|---|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | Clinical Chemistry | 862.1680 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58379 | Total testosterone 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 total testosterone 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 | 00840239015594 | GS1 |
Customer Contacts
- Phone
- 9735647555
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K000043 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius