FDA UDI
In Commercial Distribution
🇺🇸 United States
Serum Testosterone ELISA
DI: B24211TESHUE010
·
Model: 11-TESHU-E01
·
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Serum Testosterone ELISA
- Primary DI
- B24211TESHUE010
- Version / Model
- 11-TESHU-E01
- Catalog Number
- 11-TESHU-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
- 2020-09-25
- Public Version
- 2
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- cb5140b0-bc22-4167-b012-9b65556b0d3a
Device Description
Intended for the direct quantitative determination of Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use.
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 |
|---|---|---|---|---|
| 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 | B24211TESHUE010 | HIBCC |
Customer Contacts
- Phone
- 800.592.5726
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K014120 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius