Feminine Screening Kit

GUDID 07290006558930

For vaginal health

SAVYON DIAGNOSTICS LTD

Vaginal pH screening IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 07290006558930
• NIH Device Record Key: 8071f8b1-3499-4271-acd3-b48ca68ab97e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Feminine Screening Kit
• Version Model Number: F-1-VO-CVS02
• Company DUNS: 533708202
• Company Name: SAVYON DIAGNOSTICS LTD
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290006558930 [Unit of Use]
GS1	17290006558937 [Primary]

FDA Product Code

• CEN: Dye-Indicator, Ph (Urinary, Non-Quantitative)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-02
• Device Publish Date: 2026-02-22

Devices Manufactured by SAVYON DIAGNOSTICS LTD

• 07290006558930 - Feminine Screening Kit: 2026-03-02For vaginal health
• 07290006558930 - Feminine Screening Kit: 2026-03-02 For vaginal health
• 07290001913147 - SeroELISA Chlamydia IgG: 2025-06-06 The SeroELISA Chlamydia IgG kit is intended for the determination of specific IgG antibody to Chlamydia in a single human serum
• 07290001913161 - SeroELISA Chlamydia IgA: 2025-06-06 The SeroELISAChlamydia IgA kit is intended for the determination of specific IgA antibodies to Chlamydia in a single human serum
• 07290013348302 - Conjugate IgA: 2023-07-07 Conjugate IgA
• 07290013348470 - Conjugate IgM: 2023-07-07 Conjugate IgM
• 07290013348487 - Bordetella immunology reagents IgA: 2023-07-07 Bordetella immunology reagents IgA- IgA Sera pack
• 07290013348494 - Bordetella immunology reagents IgM: 2023-07-07 Bordetella immunology reagents IgM- IgM sera pack
• 07290016332193 - Serum Diluent IgM: 2023-07-07 Serum Diluent IgM