FDA Registration
Active
🇬🇧 United Kingdom
Urine CrossLaps® (CTX-I) EIA
Reg #: 8021924
·
FEI: 3002485711
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IMMUNODIAGNOSTIC SYSTEMS LTD.
- Registration Number
- 8021924
- FEI Number
- 3002485711
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10 DIDCOT WAY
- City
- Boldon Colliery Durham
- Country
- GB
Owner / Operator
- Firm Name
- IMMUNODIAGNOSTIC SYSTEMS LTD.
- Operator Number
- 8021924
- Address
- 10 DIDCOT WAY, BOLDON BUSINESS PARK
- City
- BOLDON COLLIERY
- State
- GB-NOTA
- Postal Code
- NE35 9PD
- Country
- GB
US Agent
- Business Name
- Euroimmun US Inc.
- Contact Name
- Faith Du
- Address
- 1 Bloomfield Avenue
- City
- Mountain Lakes
- State
- NJ
- ZIP
- 07046
- Country
- US
- [email protected]
- Phone
- 800 9132022 ext. 118
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Column Chromatography & Color Development, Hydroxyproline | JMM | Class 1 | Clinical Chemistry | No | 2007-01-25 |
Proprietary Names
Urine CrossLaps® (CTX-I) EIA
IDS Beta CrossLaps® (CTX-I)
Serum CrossLaps® (CTX-I) ELISA
Urine CartiLaps ® (CTX-II) EIA
Alpha CrossLaps® (CTX-I) EIA
Urine BETA CrossLaps® (CTX-I) ELISA
IDS-iSYS CTX-I (CrossLaps®)
Establishment Types
Manufacture Medical Device