FDA.reportPublic FDA data

Winx Health Inc

Primary DI
00850024942325
Brand
Winx Health Inc
Company
Get Stix Inc.
Model
1
Device description
Vaginal pH Tests
Published
2021-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNWPaper, obstetric pH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNWPaper, Obstetric PhClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850024942325PrimaryGS10
00850024942370Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850024942325008500249423258500249423250850024942325
00850024942370008500249423708500249423700850024942370

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal pH screening IVD, kit, rapid colorimetric, self-testingA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi)-quantitative screening of vaginal secretions to determine pH range, within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment to assess for pH imbalance resulting from potential bacterial or parasitic infection.

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999hello@getstix.co

Regulatory Flags#

DUNS number
117116737
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
00860002060439Winx Health Inc12020-10-01
00860002060415Winx Health Inc12019-12-31
00860002060408Stix12019-08-30
00850024942301Stix12023-04-04
00850024942615Stix12023-04-04
00850024942356Stix12021-05-15
00850024942370Stix12021-05-15
00850024942363Stix12021-05-15
00850024942073Stix12020-10-01
00860002060484Stix12020-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974246462905Safecare Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2026-03-18
06974246462608Safecare Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-09-18
06974246462257Exploro Vaginal Health pH Test DeviceSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-07-07
06974246462264Exploro Vaginal Health pH Test DeviceSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-07-07
06974246462271Exploro Vaginal Health pH Test DeviceSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-07-07
06974246462288Exploro Vaginal Health pH Test DeviceSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-07-07
06974246462295Exploro Vaginal Health pH Test DeviceSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-07-07
06974246462301Exploro Vaginal Health pH Test DeviceSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-07-07
06974246461632Welcheck Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-10-16
06974246461649Welcheck Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-10-16
06974246461656Welcheck Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-10-16
06974246461366T Testahead Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-05-30
06974246461373T Testahead Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-05-30
06974246461328Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-05-10
06974246461335Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-05-10
06974246461342Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-05-10
00612479268760McKessonMCKESSON MEDICAL-SURGICAL INC.LNW2024-02-21
00612479268777McKessonMCKESSON MEDICAL-SURGICAL INC.LNW2024-02-21
GYNXPH991GynexGYNEX CORPORATIONLNW2023-12-20
GYNXPH990GynexGYNEX CORPORATIONLNW2023-12-20
10673486001037Teco Diagnostics Vaginal pH Screening KitTECO DIAGNOSTICSLNW2023-11-03
06974246460932Testahead Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2023-09-05
00810143620016GenaCheck Vaginal pH Screening TestGenabio Diagnostics Inc.LNW2023-08-04
00810038634753Easy@home Feminine Vaginal pH Test Strip(30 tests)EASY HEALTHCARE CORPORATIONLNW2023-08-02
00810038634760Easy@home Feminine Vaginal pH Test Strip(10 tests)EASY HEALTHCARE CORPORATIONLNW2023-08-02
30810038634754Easy@home Feminine Vaginal pH Test Strip(30 tests)EASY HEALTHCARE CORPORATIONLNW2023-08-02
30810038634761Easy@home Feminine Vaginal pH Test Strip(10 tests)EASY HEALTHCARE CORPORATIONLNW2023-08-02
06970343581662HensoHenso Medical (Hangzhou) Co., Ltd.LNW2023-02-14
00850024942370StixGet Stix Inc.LNW2021-05-15