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Data / Medical devices / United States / Immuno-Biological Laboratories, Inc.

Immuno-Biological Laboratories, Inc.: FDA-registered device maker in Fridley, MN, United States, 3 510(k) clearances

Immuno-Biological Laboratories, Inc. is registered with the FDA (registration 2133982) in Fridley, MN, United States. It lists 21 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 29, 2008. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Immuno-Biological Laboratories, Inc.
FDA registration number
2133982
FEI number
3000717645
Address
8201 Central Ave. Ne., Ste. P, Fridley, MN, United States, 55432
Owner or operator
IMMUNO-BIOLOGICAL LABORATORIES, INC. (9030463)
Roles
Repackager or relabeler
First device listed
December 6, 2012
Registered through
2026
Brand names listed
Echinococcus IgG, Estradiol ELISA, Estradiol, salivary ELISA, Progesterone ELISA, Total Estrogens ELISA Kit

Devices it lists

DeviceProduct codeClassRoleSource
Antigen, Agglutinating, Echinococcus Spp.GPF1Repackager or relabeleraccessdata.fda.gov
Antigen, Fluorescent Antibody Test, Schistosoma MansoniGNH1Repackager or relabeleraccessdata.fda.gov
Antisera, Cf, Adenovirus 1-33GOA1Repackager or relabeleraccessdata.fda.gov
Antisera, Hai, Influenza Virus A, B, CGNS1Repackager or relabeleraccessdata.fda.gov
Elisa, Trichinella SpiralisMDT1Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Mumps VirusLJY1Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubeola IggLJB1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, 17-HydroxyprogesteroneJLX1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, AndrostenedioneCIZ1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, C-Peptides Of ProinsulinJKD1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)JKC1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, EstradiolCHP1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, EstriolCGI1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, EstroneCGF1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Immunoreactive InsulinCFP1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, PregnenoloneJNG1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, ProgesteroneJLS1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)CFT1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Total Estrogens, NonpregnancyJMD1Repackager or relabeleraccessdata.fda.gov
Respiratory Syncytial Virus - ElisaMCE1Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 29, 2008K062534ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONEJLXSubstantially EquivalentDrg Intl., Inc.accessdata.fda.gov
August 18, 2003K030730FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KITCDZSubstantially EquivalentDiagnostics Biochem Canada, Inc.accessdata.fda.gov
April 17, 2000K000043DRG AURICA ELISA TESTOSTERONE KITCDZSubstantially EquivalentDrg Intl., Inc.accessdata.fda.gov

Compare with other makers

Updated January 29, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.