FDA Registration
Active
🇩🇪 Germany
DEMEDITEC DIAGNOSTICS GmbH
Reg #: 3005542422
·
FEI: 3005542422
·
Expires 2026
Products
19
Proprietary Names
23
Establishment Types
2
Classifications
19
Registration Details
- Registration Name
- DEMEDITEC DIAGNOSTICS GmbH
- Registration Number
- 3005542422
- FEI Number
- 3005542422
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LISE-MEITNER-STRASSE 2
- City
- KIEL-WELLSEE Schleswig-Holstein
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K062534
Owner / Operator
- Firm Name
- DEMEDITEC DIAGNOSTICS
- Operator Number
- 9083404
- Address
- LISE-MEITNER-STRASSE 2, --
- City
- KIEL-WELLSEE
- State
- DE-NOTA
- Postal Code
- D-24145
- Country
- DE
US Agent
- Business Name
- Immuno-Biological Laboratories, Inc. (IBL-America)
- Contact Name
- Mark Kowal
- Address
- 8201 Central Ave NE, Suite 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 |
|---|---|---|---|---|---|
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2017-07-19 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2006-02-24 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2006-02-24 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2006-04-19 |
| Antisera, Cf, Parainfluenza Virus 1-4 | GQT | Class 1 | Microbiology | No | 2013-01-17 |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | Class 1 | Clinical Chemistry | No | 2013-01-17 |
| Radioimmunoassay, Corticosterone | CHA | Class 1 | Clinical Chemistry | No | 2006-05-11 |
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | LJB | Class 1 | Microbiology | No | 2013-01-17 |
| Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | GNH | Class 1 | Microbiology | No | 2017-07-19 |
| Enzyme Linked Immunoabsorbent Assay, Mumps Virus | LJY | Class 1 | Microbiology | No | 2013-01-17 |
| Antisera, Hai, Influenza Virus A, B, C | GNS | Class 1 | Microbiology | No | 2013-01-17 |
| Antigen, Agglutinating, Echinococcus Spp. | GPF | Class 1 | Microbiology | No | 2020-07-31 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2006-02-24 |
| Elisa, Trichinella Spiralis | MDT | Class 1 | Microbiology | No | 2017-07-19 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2013-01-17 |
| Respiratory Syncytial Virus - Elisa | MCE | Class 1 | Microbiology | No | 2013-01-17 |
| Antisera, Cf, Adenovirus 1-33 | GOA | Class 1 | Microbiology | No | 2013-01-17 |
| Radioimmunoassay, Androstenedione | CIZ | Class 1 | Clinical Chemistry | No | 2006-05-05 |
| Radioimmunoassay, Estriol | CGI | Class 1 | Clinical Chemistry | No | 2006-02-24 |
Proprietary Names
DHEA ELISA
DEMEDITEC DHEA-S ELISA KIT
DHEA-S ELISA
Demeditec Salivary Progesterone HS ELISA
Demeditec Progesterone ELISA
DEMEDITEC PROGESTERONE ELISA KIT
INC. IBL AMERICA
IMMUNO-BIOLOGICAL LABORATORIES
C-Peptide ELISA
IBL AMERICA CORTICOS
Schistosoma IgG EIA
DEECHG0130 Echinococcus IgG
Estradiol High Sensitive ELISA
Estradiol Salivary ELISA
Estradiol ELISA
Trichinella IgG ELISA
Salivary Testosterone ELISA
Progesterone 17-OH ELISA
IBL AMERICA 17-HYDROXYPR
IBL AMERICA ANDROSTENE
Androstenedione ELISA
DEMEDITEC ESTRIOL TEST SYSTEM
Testosterone ELISA
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device