FDA Registration
Active
🇧🇪 Belgium
DiaSource ImmunoAssays, SA
Reg #: 3009335633
·
FEI: 3009335633
·
Expires 2026
Products
19
Proprietary Names
19
Establishment Types
1
Classifications
19
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Registration Details
- Registration Name
- DiaSource ImmunoAssays, SA
- Registration Number
- 3009335633
- FEI Number
- 3009335633
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rue du Bosquet 2
- City
- Louvain-La-Neuve Brabant Wallon
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K123364
Owner / Operator
- Firm Name
- DIAsource ImmunoAssays, SA
- Operator Number
- 10037912
- Address
- Rue du Bosquet, 2
- City
- Louvain-La-Neuve
- State
- BE-NOTA
- Postal Code
- 1348
- Country
- BE
US Agent
- Business Name
- Immuno-Biological Laboratories, Inc. (IBL-America)
- Contact Name
- Mark Kowal
- Address
- 8201 Central Ave Ne Ste P
- City
- Minneapolis
- State
- MN
- ZIP
- 55432
- Country
- US
- [email protected]
- Phone
- 763 7802955
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | OAM | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Radioimmunoassay, Androstenedione | CIZ | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Radioimmunoassay, Glucagon | JME | Class 1 | Clinical Chemistry | No | 2018-09-03 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2017-08-04 |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Radioimmunoassay, Compound S (11-Deoxycortisol) | JKB | Class 1 | Clinical Chemistry | No | 2018-03-27 |
| Radioimmunoassay, Estrone | CGF | Class 1 | Clinical Chemistry | No | 2014-08-04 |
| Radioimmunoassay, Total Thyroxine | CDX | Class 2 | Clinical Chemistry | No | 2022-08-22 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2017-08-04 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2017-08-04 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2013-07-22 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Sperm, Antigen, Antiserum, Control | DFQ | Class 1 | Immunology | No | 2019-01-28 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2014-06-02 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2020-12-31 |
Proprietary Names
IGFBP-3 ELISA
E2-RIA-CT
ANDROSTENEDIONE -RIA-CT
Glucagon
DHEA-S
PRL
17 OH
Insulin
11 DOC RIA-CT
Estrone RIA
T4-RIA-CT
LHsp
FSH
C PEP ELISA
25 OH vit D Total ELISA
PROG-RIA-CT
Sperm Antibody
T3-RIA-CT
Strep B
Establishment Types
Manufacture Medical Device