FDA UDI
In Commercial Distribution
🇺🇸 United States
IDS-iSYS Free Testosterone
DI: 05060169691230
·
Model: IS-5300
·
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IDS-iSYS Free Testosterone
- Primary DI
- 05060169691230
- Version / Model
- IS-5300
- Company Name
- IMMUNODIAGNOSTIC SYSTEMS LIMITED
- Labeler DUNS
- 494268600
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-03
- Public Version
- 1
- Public Version Date
- 2025-11-11
- Public Version Status
- New
- Public Device Record Key
- b46f893c-c929-40c8-a36d-77be0e4a1cd1
Device Description
The IDS-iSYS Free Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of free testosterone in human serum or plasma on the IDS System. Results are to be used as an aid in the diagnosis of androgen disorders
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
- MR Safe
- 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 |
|---|---|---|---|---|
| 63762 | Free testosterone IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free testosterone in a clinical specimen, using a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060169691230 | GS1 |
Customer Contacts
- Phone
- +4401915190660
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240865 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the cartridge and calibrators in an upright position in the dark. Do not freeze the cartridge or the calibrators.