IDS-iSYS Total Testosterone
Immunodiagnostic Systems Limited · Clinical Chemistry
Open FDA's page for this record- Third party flag
- N
- City
- Tyne & Wear
- Advisory committee description
- Clinical Chemistry
- Address 1
- 10 Didcot Way
- Address 2
- Boldon Business Park
- Statement or summary
- Summary
- Product code
- CDZ
- Zip code
- NE35 9PD
- Applicant
- Immunodiagnostic Systems Limited
- Decision date
- 2026-04-15
- Decision code
- SESE
- Country code
- GB
- Device name
- IDS-iSYS Total Testosterone
- Advisory committee
- CH
- Contact
- Mick Henderson
- K number
- K252728
- Date received
- 2025-08-28
- Review advisory committee
- CH
- Postal code
- NE35 9PD
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.1680
- Device class
- 1
- Registration number
- 9710337, 3012963943, 1827821, 1832216, 2245285, 2032682, 9612316, 3005529799, 1415939, 2432235, 2419955, 9615037, 3007118747, 3007111389, 1222302, 8021924, 3002800697, 2517506, 2029372, 3007361513, 1219913, 3002806944, 2032839, 3011989923, 8010132, 3004192065, 3005984081, 8023018, 3005333358, 2133982, 3003030793, 3002809144, 3033967997, 2032087, 1319681, 3000308930, 9610126, 2182595, 3009092698, 3003559191 +17 more
- FEI number
- 1827821, 3012963943, 1832216, 2245285, 1000306617, 3007019572, 3005529799, 1415939, 2432235, 2419955, 3007118747, 3007111389, 3002800697, 3002807272, 2517506, 3003952975, 3007361513, 1219913, 3002806944, 3003355251, 3011989923, 3004192065, 3004185580, 3005984081, 3002806808, 3005333358, 1000121039, 3002806559, 3003030793, 3002809144, 3002808140, 1000442352, 1000136573, 3033967997, 3000308930, 2967, 2182595, 3000717645, 3009092698, 3003559191 +17 more