FDA Registration
Active
🇮🇱 Israel
SAVYON DIAGNOSTICS LTD.
Reg #: 8030124
·
FEI: 3003206361
·
Expires 2026
Products
13
Proprietary Names
24
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- SAVYON DIAGNOSTICS LTD.
- Registration Number
- 8030124
- FEI Number
- 3003206361
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3 HABOSEM ST.
- City
- ASHDOD Southern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K914327
Owner / Operator
- Firm Name
- SAVYON DIAGNOSTICS, LTD.
- Operator Number
- 8030129
- Address
- 3 HABOSEM ST., --
- City
- ASHDOD
- State
- IL-NOTA
- Postal Code
- 7761003
- Country
- IL
- Correspondent
- Michal - Ben Akun
US Agent
- Business Name
- Jant Pharmacal Corp
- Contact Name
- Samuel Elkin
- Address
- 16530 Ventura Blvd., Suite 512
- City
- Encino
- State
- CA
- ZIP
- 91436
- Country
- US
- [email protected]
- Phone
- 818 9868530 ext. 111
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagent, Immunoassay, Igg | KTO | Class 1 | Immunology | No | 2014-09-03 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2023-05-18 |
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2025-06-19 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2025-02-20 |
| Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | LJC | Class 1 | Microbiology | No | 2009-06-24 |
| Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | LJZ | Class 1 | Microbiology | No | 2009-06-24 |
| Antisera, Fluorescent, B. Pertussis | GOZ | Class 1 | Microbiology | No | 2009-12-20 |
| Culture Media, Propagating Transport | JSN | Class 1 | Microbiology | No | 2024-03-13 |
| Whole Human Serum, Antigen, Antiserum, Control | DGR | Class 1 | Immunology | No | 2012-12-10 |
| Kit, Screening, Urine | JXA | Class 1 | Microbiology | No | 2009-06-24 |
| Culture Media, Selective And Differential | JSI | Class 1 | Microbiology | No | 2024-03-13 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2012-12-10 |
| Candida Spp., Direct Antigen, Id | LRF | Class 2 | Microbiology | No | 2007-07-23 |
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
Bordetella Pertussis IgG
SeroPertussis Toxin IgG
VAGINAL YEAST test (POC use)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)