FDA.reportPublic FDA data

Clearblue

Primary DI
00633472602245
Brand
Clearblue
Company
SPD SWISS PRECISION DIAGNOSTICS GMBH
Model
Menopause Stage Indicator
Catalog number
N/A
Device description
CB Menopause Stage Indicator 5ct US
Published
2023-07-31
Public version status
Update
Distribution status
Not 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
NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGATest, Follicle Stimulating Hormone (Fsh), Over The CounterClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10633472602242PackageGS16Not in Commercial Distribution
00633472602245PrimaryGS10
00633472000577Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063347260224210633472602242
00633472602245006334726022456334726022450633472602245
00633472000577006334720005776334720005770633472000577

GMDN Terms#

Term, Definition table
TermDefinition
Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testingA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of follicle stimulating hormone (FSH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment as an aid in the diagnosis of conditions related to reproductive health (e.g., menopause, infertility).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-321-3279xx@xx.xx

Regulatory Flags#

DUNS number
483609579
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00633472602313ClearblueEarly Digital Pregnancy TestN/A2024-02-06
00633472602559ClearblueSmart Ovulation TestN/A2026-05-06
00633472602566ClearblueSmart Ovulation TestN/A2026-05-06
00633472602573ClearblueSmart Ovulation TestN/A2026-05-06
00381519194696ClearbluePeriod Cycle Tracker- CBApp-1N/A2026-03-23
00633472600760ClearblueDigital Ovulation Test2019-04-17
00633472601156Clearblue Pregnancy Test Combo Pack2016-09-14
00633472602375ClearblueBirth Control KitN/A2024-12-11
00633472602382ClearblueDigital Ovulation TestN/A2024-10-30
00633472602535ClearblueDigital Ovulation TestN/A2025-07-30
10633472602532ClearblueDigital Ovulation TestN/A2025-07-30
00041163502987Equaline Digital Pregnancy Test2021-04-19
00041163504448EqualineDigital Wide-Tip Pregnancy TestN/A2025-03-31
10041163504445EqualineDigital Wide-Tip Pregnancy TestN/A2025-03-31
00633472602481ClearblueEarly Assurance Combo Pregnancy TestsN/A2025-02-05
10633472602488ClearblueEarly Assurance Combo Pregnancy TestsN/A2025-02-05
00633472276897Clearblue Digital Pregnancy Test2019-07-29
00633472600401ClearblueAdvanced Digital Ovulation Test2019-04-17
00633472600425ClearblueAdvanced Digital Ovulation Test2019-06-07
00633472601149Clearblue Pregnancy Test with Smart Countdown2016-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809408864113Surearly SMARTSugentech Inc._Osong BranchNGA2026-05-08
06952062712664Follicle-Stimulating Hormone (FSH) Menopause testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGA2026-03-20
06952062712688Follicle-Stimulating Hormone (FSH) Menopause testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGA2026-03-20
00045611010055SURESIGN™ Menopause (FSH) Rapid TestGuangzhou Decheng Biotechnology Co., LTDNGA2026-01-28
50045611010050SURESIGN™ Menopause (FSH) Rapid TestGuangzhou Decheng Biotechnology Co., LTDNGA2026-01-28
20045611954018EPT Menopause (FSH) Rapid TestHangzhou AllTest Biotech Co., Ltd.NGA2025-12-10
50045611954019EPT Menopause (FSH) Rapid TestHangzhou AllTest Biotech Co., Ltd.NGA2025-12-10
06942598202326One Step FSH Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGA2025-10-10
06942598202333One Step FSH Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGA2025-10-10
06942598202340One Step FSH Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGA2025-10-10
00810038638072Easy@Home FSH Urine Test (5 Tests)EASY HEALTHCARE CORPORATIONNGA2025-10-06
06936983131025One Step One Step FSH Urine test stripHangzhou AllTest Biotech Co., Ltd.NGA2025-08-29
06936983131018One Step FSH Urine midstream TestHangzhou AllTest Biotech Co., Ltd.NGA2025-08-29
86936983131021One Step One Step FSH Urine test stripHangzhou AllTest Biotech Co., Ltd.NGA2025-08-29
00850035206393ProovMfb Fertility, Inc.NGA2025-08-15
00816862027242HORMONElife™WONDFO USA CO., LTD.NGA2025-07-03
10816862027249HORMONElife™WONDFO USA CO., LTD.NGA2025-07-03
08809408863475Surearly SMART Menopause TestSugentech Inc._Osong BranchNGA2025-05-15
08809408863499Surearly SMARTSugentech Inc._Osong BranchNGA2025-05-15
00810143620214GenaCheck® FSH At-Home Menopause TestGenabio Diagnostics Inc.NGA2025-02-26
00850059915370GoldN Easy to Use FSH TestNOVODX CorporationNGA2025-01-24
00816862026078WondfoWONDFO USA CO., LTD.NGA2024-12-24
10816862026075WondfoWONDFO USA CO., LTD.NGA2024-12-24
00860011489153VivooVIVOSENS INC.NGA2024-11-25
10860011489150VivooVIVOSENS INC.NGA2024-11-25
00816862024418BABYLifeWONDFO USA CO., LTD.NGA2024-05-22
10816862024415BABYLifeWONDFO USA CO., LTD.NGA2024-05-22
10633472602242ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGA2023-07-31
00810038634692One Step FSH Urine Test Strip(10 Tests)EASY HEALTHCARE CORPORATIONNGA2023-07-19
10810038634699One Step FSH Urine Test Strip(10 Tests)EASY HEALTHCARE CORPORATIONNGA2023-07-19