Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2133982

FEI Number

3000717645

Entity Name

IMMUNO-BIOLOGICAL LABORATORIES, INC.

City/State/Country

Fridley, MN, US

Establishment Address

8201 CENTRAL AVE. NE., STE. P, Fridley, MN 55432, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

IMMUNO-BIOLOGICAL LABORATORIES, INC. (Owner Number: 9030463)

Owner / Operator Contact Address

8201 CENTRAL AVE. NE., STE. P, --, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Progesterone ELISA Estradiol ELISA Estradiol, salivary ELISA Total Estrogens ELISA Kit Echinococcus IgG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2017-07-19
GOA	Antisera, Cf, Adenovirus 1-33	Microbiology	Class 1	866.3020	2017-07-06
CGI	Radioimmunoassay, Estriol	Clinical Chemistry	Class 1	862.1265	2013-01-24
MDT	Elisa, Trichinella Spiralis	Microbiology	Class 1	866.3850	2017-07-19
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2013-01-24
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2017-07-06
LJB	Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	Microbiology	Class 1	866.3520	2013-01-25
CIZ	Radioimmunoassay, Androstenedione	Clinical Chemistry	Class 1	862.1075	2013-01-24
GNS	Antisera, Hai, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2017-07-14
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2013-01-24
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2013-01-24
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2013-01-25
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2013-01-24
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2017-07-19
JMD	Radioimmunoassay, Total Estrogens, Nonpregnancy	Clinical Chemistry	Class 1	862.1275	2018-11-20
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	2013-01-25
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2012-12-06
GNH	Antigen, Fluorescent Antibody Test, Schistosoma Mansoni	Microbiology	Class 1	866.3600	2017-07-19
GPF	Antigen, Agglutinating, Echinococcus Spp.	Microbiology	Class 1	866.3200	2020-07-31

Official Correspondent

Mark Kowal

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IMMUNO-BIOLOGICAL LABORATORIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780273	Flow Laboratories, Inc.	INFLUENZA HI PRESERUM	1978-02-28
K971921	Monobind	PROLACTIN (PRL) HORMONE MICROPLATE ELISA	1997-06-24

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3005948789	INVITRON	Monmouth Monmouthshire, GB
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2133982. Last updated year: 2026. Please use registration number 2133982 when referencing this establishment in official correspondence.