FDA Registration
Active
🇪🇸 Spain
Alinity i Intact PTH Controls
Reg #: 9610746
·
FEI: 3002806557
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOKIT S.A.
- Registration Number
- 9610746
- FEI Number
- 3002806557
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- AV. CAN MONTCAU 7
- City
- LLISSA D AMUNT Barcelona
- Country
- ES
Owner / Operator
- Firm Name
- BIOKIT S.A.
- Operator Number
- 8030752
- Address
- AV CAN MONTCAU, 7, --
- City
- LLISSA D'AMUNT, BARCELONA
- State
- ES-B
- Postal Code
- 08186
- Country
- ES
- Correspondent
- ANGELS - ROMA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-07-13 |
Proprietary Names
Alinity i Intact PTH Controls
Alinity i DHEA-S Controls
Alinity c ASO Control I
Alinity c ASO Control II
Alinity c Lp(a) Control Kit
Alinity i C-Peptide Controls
Atellica IM Herpes-2 IgG Quality Control (HSV2 QC)
ADVIA Centaur Herpes-2 IgG (HSV2) Quality Control
Atellica IM Herpes-1 IgG Quality Control (HSV1 QC)
ADVIA Centaur Herpes-1 IgG (HSV1) Quality Control
Establishment Types
Manufacture Medical Device