FDA.reportPublic FDA data

Florisense Preconception Vaginal Health Test

Primary DI
07290006558121
Brand
Florisense Preconception Vaginal Health Test
Company
PEPTONIC MEDICAL ISRAEL LTD
Model
F-1-VO-FLPR
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
17290006558128PrimaryGS10
07290006558121Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729000655812817290006558128
07290006558121072900065581217290006558121

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600850111
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
17290006558159Clinistix Vaginal Health TestF-1-VO-CLSM022023-06-28
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
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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