FDA.reportPublic FDA data

Gynex

Primary DI
GYNXPH991
Brand
Gynex
Company
GYNEX CORPORATION
Model
PH-99
Published
2023-12-20
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
LNWPaper, Obstetric Ph

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032161000PHEM-ALERTFemtek,Llc.2003-09-30LNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
GYNXPH991PrimaryHIBCC0
GYNXPH990Unit of UseHIBCC0

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
012997685
Device count
12
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
GYNX32500Gynex32502023-12-13
GYNX32550Gynex32552023-12-13
GYNX80091Gynex80092023-12-19
GYNX80241Gynex80242023-12-19
GYNX80721Gynex80722023-12-19
GYNX81001Gynex81002023-12-19
GYNX81031Gynex81032023-12-19
GYNX82001Gynex82002023-12-19
GYNX292001Gynex29-2002023-12-26
GYNX293001Gynex29-3002023-12-26
GYNX298501Gynex29-8502023-12-26
GYNX31301Gynex31302023-12-26
GYNX31351Gynex31352023-12-26
GYNX32071Gynex32052023-12-26
GYNX16000Gynex16002023-12-26
GYNX291000Gynex29-1002023-12-26
GYNX292000Gynex29-3002023-12-26
GYNX293500Gynex29-3502023-12-26
GYNX295500Gynex29-5502023-12-26
GYNX297000Gynex29-7002023-12-26

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