FDA Registration
Active
🇺🇸 United States
IMMUNO-BIOLOGICAL LABORATORIES, INC.
Reg #: 2133982
·
FEI: 3000717645
·
Expires 2026
Products
21
Proprietary Names
5
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- IMMUNO-BIOLOGICAL LABORATORIES, INC.
- Registration Number
- 2133982
- FEI Number
- 3000717645
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8201 CENTRAL AVE. NE., STE. P
- City
- Fridley
- State
- MN
- ZIP
- 55432
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062534
Owner / Operator
- Firm Name
- IMMUNO-BIOLOGICAL LABORATORIES, INC.
- Operator Number
- 9030463
- Address
- 8201 CENTRAL AVE. NE., STE. P, --
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
- Correspondent
- Mark A Kowal
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2017-07-19 |
| Antisera, Cf, Adenovirus 1-33 | GOA | Class 1 | Microbiology | No | 2017-07-06 |
| Radioimmunoassay, Estriol | CGI | Class 1 | Clinical Chemistry | No | 2013-01-24 |
| Elisa, Trichinella Spiralis | MDT | Class 1 | Microbiology | No | 2017-07-19 |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | Class 1 | Clinical Chemistry | No | 2013-01-24 |
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | LJB | Class 1 | Microbiology | No | 2013-01-25 |
| Radioimmunoassay, Androstenedione | CIZ | Class 1 | Clinical Chemistry | No | 2013-01-24 |
| Antisera, Hai, Influenza Virus A, B, C | GNS | Class 1 | Microbiology | No | 2017-07-14 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2013-01-24 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2013-01-24 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2013-01-25 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2013-01-24 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2017-07-19 |
| Radioimmunoassay, Total Estrogens, Nonpregnancy | JMD | Class 1 | Clinical Chemistry | No | 2018-11-20 |
| Enzyme Linked Immunoabsorbent Assay, Mumps Virus | LJY | Class 1 | Microbiology | No | 2013-01-25 |
| Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | GNH | Class 1 | Microbiology | No | 2017-07-19 |
| Antigen, Agglutinating, Echinococcus Spp. | GPF | Class 1 | Microbiology | No | 2020-07-31 |
| Radioimmunoassay, Pregnenolone | JNG | Class 1 | Clinical Chemistry | No | 2013-01-24 |
| Respiratory Syncytial Virus - Elisa | MCE | Class 1 | Microbiology | No | 2017-07-14 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2013-01-24 |
| Radioimmunoassay, Estrone | CGF | Class 1 | Clinical Chemistry | No | 2013-01-24 |
Proprietary Names
Progesterone ELISA
Estradiol ELISA
Estradiol, salivary ELISA
Total Estrogens ELISA Kit
Echinococcus IgG
Establishment Types
Repack or Relabel Medical Device