FDA Registration
Active
🇩🇪 Germany
IMMUNDIAGNOSTIK AG
Reg #: 3005452690
·
FEI: 3005452690
·
Expires 2026
Products
10
Proprietary Names
13
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- IMMUNDIAGNOSTIK AG
- Registration Number
- 3005452690
- FEI Number
- 3005452690
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Stubenwald-Allee 8a
- City
- Bensheim Hesse
- Country
- DE
Owner / Operator
- Firm Name
- Immundiagnostik AG
- Operator Number
- 10053423
- Address
- Stubenwald-Allee 8a
- City
- Bensheim
- State
- Hesse
- Postal Code
- 64625
- Country
- DE
- Correspondent
- Swantje Holbrook
US Agent
- Business Name
- Immundiagnostik, Inc.
- Contact Name
- Terance Fisher
- Address
- 400 Bedford Street, Suite #104
- City
- Manchester
- State
- NH
- ZIP
- 03101
- Country
- US
- [email protected]
- Phone
- 888 4339020 ext. 1002
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Free Secretory Component, Antigen, Antiserum, Control | DAJ | Class 2 | Immunology | No | 2018-12-13 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2020-10-26 |
| Alpha-2-Macroglobulin, Antigen, Antiserum, Control | DEB | Class 2 | Immunology | No | 2020-10-26 |
| M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase) | JMQ | Class 1 | Clinical Chemistry | No | 2018-12-13 |
| N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin | JKW | Class 1 | Clinical Chemistry | No | 2020-10-23 |
| P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | JNN | Class 1 | Clinical Chemistry | No | 2016-12-05 |
| N-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin | JKX | Class 1 | Clinical Chemistry | No | 2020-10-26 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2018-12-13 |
| Retinol-Binding Protein, Antigen, Antiserum, Control | CZS | Class 1 | Immunology | No | 2020-10-26 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2017-01-12 |
Proprietary Names
IDK® sIgA ELISA
Albumin, human
Albumin Immunological Test System
Alpha-2-macroglobulin Immunological Test System
Lysozyme ELISA
Chymotrypsin Elisa
Chymotrypsin Test System
ox-LDL/MDA Adduct ELISA
Retinol-binding protein Immunological Test System
IDKhighX® Tube
stool preparation system, filled with extraction buffer IDK Extract®
stool preparation system (empty tube)
OmicSnap® Tube
Establishment Types
Manufacture Medical Device