Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030124

FEI Number

3003206361

Entity Name

SAVYON DIAGNOSTICS LTD.

City/State/Country

ASHDOD Southern, IL

Establishment Address

3 HABOSEM ST., ASHDOD Southern 7761003, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SAVYON DIAGNOSTICS, LTD. (Owner Number: 8030129)

Owner / Operator Contact Address

3 HABOSEM ST., --, ASHDOD, IL-NOTA 7761003, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K921045

PMA Number

N/A

All Registered Proprietary Names

Analyte specific reagent Serum Diluent IgM, Conjugate IgM, Conjugate IgA FloRite Florisense Preconception Vaginal Health Test; Florisense Vaginal Health Test Screening Kit for Vaginal Health; Vagi-Screen Vaginal Health Test; VagiVital VS; VS-SENSE OTC Clinistix Vaginal Health Test Kit; Equate; Feminine Screening Kit SeroELISA Chlamydia IgA SeroMP IgG, IgM, IgA AL-SENSE; AmniScreen(TM) Monistat Pro; Nuvetest; VS-SENSE SeroPertussis IgA/IgM SeroPertussis Toxin IgA CHROMOSTREAK IBDX immunology control URISCREEN (UTI screening OTC use) DIPSTREAK IBDX ASR PLATE CHITOBIOSIDE, IBDX ASR PLATE LAMINARIBIOSIDE, IBDX ASR PLATE MANNOBIOSIDE, IBDX ASR PLATE SACCHAROMYCES Bordetella immunology reagents IgA, Bordetella immunology reagents IgM SeroELISA Chlamydia IgG URISCREEN (UTI screening) DIASLIDE URINE CULTURING DEVICE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KTO	Reagent, Immunoassay, Igg	Immunology	Class 1	866.5530	2014-09-03
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2023-05-18
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2025-06-19
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2025-02-20
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	Microbiology	Class 1	866.3120	2009-06-24
LJZ	Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.	Microbiology	Class 1	866.3375	2009-06-24
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2025-02-03
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2025-02-03
GOZ	Antisera, Fluorescent, B. Pertussis	Microbiology	Class 1	866.3065	2009-12-20
JSN	Culture Media, Propagating Transport	Microbiology	Class 1	866.2390	2024-03-13
DGR	Whole Human Serum, Antigen, Antiserum, Control	Immunology	Class 1	866.5700	2012-12-10
JXA	Kit, Screening, Urine	Microbiology	Class 1	866.2660	2009-06-24
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2024-03-13
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2012-12-10
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	Microbiology	Class 1	866.3120	2009-06-24
JXA	Kit, Screening, Urine	Microbiology	Class 1	866.2660	2009-06-24
JXA	Kit, Screening, Urine	Microbiology	Class 1	866.2660	2000-04-13

Official Correspondent

Michal Ben Akun

US Agent Details

Samuel Elkin Business: Jant Pharmacal Corp Email: elkin@Jantdx.com Phone: (818) 9868530

Related Public Records

Same Entity

SAVYON DIAGNOSTICS, LTD.

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
K862389	Otisville Biotech, Inc.	BIOTIS ACETAMIDE AGAR	1986-07-03
K811644	Hardy Media	HEKTOEN ENTERIC AGAR	1981-07-02
K832535	Otisville Biotech, Inc.	HEKTOEN ENTERIC AGAR PLATE	1983-10-04
K811331	Acumedia Manufacturers, Inc.	SF BROTH	1981-05-29
K872058	Orion Corp.	ORICULT-N CULTURE-PADDLE	1987-06-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030124. Last updated year: 2026. Please use registration number 8030124 when referencing this establishment in official correspondence.