FDA.reportPublic FDA data

GenaCheck Vaginal pH Screening Test

Primary DI
00810143620016
Brand
GenaCheck Vaginal pH Screening Test
Company
Genabio Diagnostics Inc.
Model
RA9-E02303
Published
2023-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
00810143620016PrimaryGS10
00810143620078Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143620016008101436200168101436200160810143620016
00810143620078008101436200788101436200780810143620078

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118586095
Device count
3
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810143620221GenaCheck® Early Result Pregnancy TestN/A2025-02-26
00810143620115GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E197002025-01-13
00810143620139GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E198002025-01-13
00810143620146GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E199002025-01-13
00810143620153GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E201002025-01-13
00860008954800GenaCheck™ Fentanyl Urine Home-Use Test CassetteRA9-E02525RA9-E025012024-06-14
00810143620122GenaCheck® COVID-19 Rapid Self-Test 2TN/A2026-01-21
00810143620382GenaCheck® COVID-19 Rapid Self-Test 20TN/A2026-01-21
00810143620399GenaCheck® COVID-19 Rapid Self-Test 4TN/A2026-01-21
00810143620344GenaCheck® COVID-19/Flu A&B Rapid Self-TestRA9-E024022025-05-19
00810143620368GenaCheck® COVID-19/Flu A&B Rapid Self-TestRA9-E024042025-05-19
00810143620214GenaCheck® FSH At-Home Menopause TestN/A2025-02-26
00810143620184Genabio COVID-19 Rapid Self-Test KitN/A2025-01-13
00810143620191GenaCheck®LH At-Home Ovulation Prediction TestN/A2025-01-13
00810143620207GenaCheck®PdG At-Home Ovulation Confirmation TestN/A2025-01-13
00860008954817GenaCheck®Fentanyl Urine Test CassetteN/ARA9-E025252025-01-13
00810143620009GenaCheck Rapid Self-Test Kit For Urinary Tract InfectionsRA9-E018022023-10-06
00810143620047GenaCheck Alcohol Rapid Self-Test KitRA9-E019052023-10-06
00810143620054GenaCheck 5-Drug Rapid Self-Test KitRA9-E021052023-10-06
00810143620061GenaCheck 12-Drug Rapid Self-Test KitRA9-E019022023-10-06

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
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
00850024942325Winx Health IncGet Stix Inc.LNW2021-05-15
00850024942370StixGet Stix Inc.LNW2021-05-15