FDA.reportPublic FDA data

Teco Diagnostics Vaginal pH Screening Kit

Primary DI
10673486001037
Brand
Teco Diagnostics Vaginal pH Screening Kit
Company
TECO DIAGNOSTICS
Model
MRS-OBGYN-VPH
Catalog number
MRS-OBGYN-VPH
Device description
Teco Diagnostics Vaginal pH Screening Kit is an easy, single-use device designed for testing pH in the vagina.
Published
2023-11-03
Public version status
New
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
10673486001037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600103710673486001037

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7144631111hello@tecodiagnostics.com

Regulatory Flags#

DUNS number
185067774
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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10673486001013Albumin Reagent SetA502-480A502-4802023-07-07
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10673486002478GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-06-10
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10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MatrixTC-Matrix2025-05-28
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10673486000726Teco Diagnostics Glucopad Blood Glucose Test StripsGlucopad Blood Glucose Test StripsG852-B-0022024-12-19
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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
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