Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005542422

FEI Number

3005542422

Entity Name

DEMEDITEC DIAGNOSTICS GmbH

City/State/Country

KIEL-WELLSEE Schleswig-Holstein, DE

Establishment Address

LISE-MEITNER-STRASSE 2, KIEL-WELLSEE Schleswig-Holstein D-24145, DE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DEMEDITEC DIAGNOSTICS (Owner Number: 9083404)

Owner / Operator Contact Address

LISE-MEITNER-STRASSE 2, --, KIEL-WELLSEE, DE-NOTA D-24145, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DHEA ELISA DEMEDITEC DHEA-S ELISA KIT DHEA-S ELISA Demeditec Salivary Progesterone HS ELISA Demeditec Progesterone ELISA DEMEDITEC PROGESTERONE ELISA KIT INC. IBL AMERICA IMMUNO-BIOLOGICAL LABORATORIES C-Peptide ELISA IBL AMERICA CORTICOS Schistosoma IgG EIA DEECHG0130 Echinococcus IgG Estradiol High Sensitive ELISA Estradiol Salivary ELISA Estradiol ELISA Trichinella IgG ELISA Salivary Testosterone ELISA Progesterone 17-OH ELISA IBL AMERICA 17-HYDROXYPR IBL AMERICA ANDROSTENE Androstenedione ELISA

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
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2006-02-24
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2006-02-24
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2006-04-19
GQT	Antisera, Cf, Parainfluenza Virus 1-4	Microbiology	Class 1	866.3400	2013-01-17
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2013-01-17
CHA	Radioimmunoassay, Corticosterone	Clinical Chemistry	Class 1	862.1200	2006-05-11
LJB	Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	Microbiology	Class 1	866.3520	2013-01-17
GNH	Antigen, Fluorescent Antibody Test, Schistosoma Mansoni	Microbiology	Class 1	866.3600	2017-07-19
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	2013-01-17
GNS	Antisera, Hai, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2013-01-17
GPF	Antigen, Agglutinating, Echinococcus Spp.	Microbiology	Class 1	866.3200	2020-07-31
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2006-02-24
MDT	Elisa, Trichinella Spiralis	Microbiology	Class 1	866.3850	2017-07-19
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2013-01-17
MCE	Respiratory Syncytial Virus - Elisa	Microbiology	Class 1	866.3480	2013-01-17
GOA	Antisera, Cf, Adenovirus 1-33	Microbiology	Class 1	866.3020	2013-01-17
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2006-05-05
CIZ	Radioimmunoassay, Androstenedione	Clinical Chemistry	Class 1	862.1075	2006-05-05

Official Correspondent

No official correspondent registered.

US Agent Details

Mark Kowal Business: Immuno-Biological Laboratories, Inc. (IBL-America) Email: mkowal@ibl-america.com Phone: (763) 7802955

Related Public Records

Same Entity

DEMEDITEC DIAGNOSTICS

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005542422. Last updated year: 2026. Please use registration number 3005542422 when referencing this establishment in official correspondence.