FDA Registration
Active
🇺🇸 United States
IMMUNDIAGNOSTIK, INC.
Reg #: 3015189693
·
FEI: 3015189693
·
Expires 2026
Products
5
Proprietary Names
5
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- IMMUNDIAGNOSTIK, INC.
- Registration Number
- 3015189693
- FEI Number
- 3015189693
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 150 Dow Street, Ste 430
- City
- Manchester
- State
- NH
- ZIP
- 03101
- Country
- US
Owner / Operator
- Firm Name
- Immundiagnostik, Inc.
- Operator Number
- 10059103
- Address
- 150 Dow St, Suite 430
- City
- Manchester
- State
- NH
- Postal Code
- 03101
- Country
- US
- Correspondent
- Terance Fisher
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase) | JMQ | Class 1 | Clinical Chemistry | No | 2018-12-18 |
| P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | JNN | Class 1 | Clinical Chemistry | No | 2018-11-30 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2018-11-30 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2018-12-18 |
| Free Secretory Component, Antigen, Antiserum, Control | DAJ | Class 2 | Immunology | No | 2018-12-18 |
Proprietary Names
Lysozyme ELISA
IDK® Pancreatic Elastase ELISA
IDK Extract®
ox-LDL/MDA Adduct ELISA
IDK® sIgA
Establishment Types
Complaint File Establishment per 21 CFR 820.198