Immundiagnostik AG
Bensheim Hesse, DE
IMMUNDIAGNOSTIK AG appears in FDA device records in Bensheim Hesse, DE. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005452690 | 3005452690 | IMMUNDIAGNOSTIK AG | Stubenwald-Allee 8a, Bensheim Hesse 64625 DE | 2026 | |
| 3015189693 | 3015189693 | IMMUNDIAGNOSTIK, INC. | 150 Dow Street, Manchester, NH 03101 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DCFAlbumin, Antigen, Antiserum, Control
- DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- DAJFree Secretory Component, Antigen, Antiserum, Control
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- JMQM. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)
- JKWN-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin
- JKXN-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin
- JNNP-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin
- CZSRetinol-Binding Protein, Antigen, Antiserum, Control
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1603-2023 | Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates | Marketed without a 510k | Class II | Completed |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain