FDA.reportPublic FDA data

Clinistix Vaginal Health Test

Primary DI
17290006558159
Brand
Clinistix Vaginal Health Test
Company
PEPTONIC MEDICAL ISRAEL LTD
Model
F-1-VO-CLSM02
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CENDye-Indicator, Ph (Urinary, Non-Quantitative)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290006558159PrimaryGS10
07290006558152Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729000655815917290006558159
07290006558152072900065581527290006558152

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal pH screening IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative determination of the pH range of vaginal secretionse within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
600850111
Device count
2
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290006558098VagiVital VSF-1-VO-VVUS-022023-06-28
17290006558104Vagi-Screen Vaginal Health TestF-1-VO-VASC-022023-06-28
17290006558111Florisense Vaginal Health TestF-1-VO-AMZU22023-06-28
17290006558128Florisense Preconception Vaginal Health TestF-1-VO-FLPR2023-06-28
17290006558135Feminine Screening KitF-1-VO-CVS022023-06-28
17290006558142EquateF-1-VO-WAL022023-06-28
17290006558166VS-SENSEF-VS-HS22023-06-28
17290006558173NuvetestF-1-VS-EX2023-06-28
17290006558180Monistat ProF-1-VS-MON252023-06-28
07290006558091VagiVital VSF-1-VO-VVUS-022023-06-28
07290006558107Vagi-Screen Vaginal Health TestF-1-VO-VASC-022023-06-28
07290006558114Florisense Vaginal Health TestF-1-VO-AMZU22023-06-28
07290006558121Florisense Preconception Vaginal Health TestF-1-VO-FLPR2023-06-28
07290006558138Feminine Screening KitF-1-VO-CVS022023-06-28
07290006558145EquateF-1-VO-WAL022023-06-28
07290006558152Clinistix Vaginal Health TestF-1-VO-CLSM022023-06-28
07290006558169VS-SENSEF-VS-HS22023-06-28
07290006558176NuvetestF-1-VS-EX2023-06-28
07290006558183Monistat ProF-1-VS-MON252023-06-28
17290006558081VS-SENSE OTCF-1-VOCS-022023-06-27

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Primary DI, Brand, Company table
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