FDA UDI
In Commercial Distribution
🇺🇸 United States
IDS-iSYS Total Testosterone
DI: 05060169690721
·
Model: N/A
·
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IDS-iSYS Total Testosterone
- Primary DI
- 05060169690721
- Version / Model
- N/A
- Catalog Number
- IS-5000
- Company Name
- IMMUNODIAGNOSTIC SYSTEMS LIMITED
- Labeler DUNS
- 494268600
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-17
- Public Version
- 1
- Public Version Date
- 2026-04-27
- Public Version Status
- New
- Public Device Record Key
- f4d5d884-4a50-42f9-a2d0-3157ecdf608d
Device Description
The IDS-iSYS Total Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of testosterone in human serum or plasma on the IDS system. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
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 |
|---|---|---|---|---|
| 61077 | Total 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 total 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 | 05060169690721 | GS1 |
Customer Contacts
- Phone
- +441915190660
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252728 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the cartridge in an upright position in the dark. Do not freeze the cartridge