FDA.reportPublic FDA data

Clearblue

Primary DI
00633472602573
Brand
Clearblue
Company
SPD SWISS PRECISION DIAGNOSTICS GMBH
Model
Smart Ovulation Test
Catalog number
N/A
Device description
CLEARBLUE OVUL SOT 50CT US
Published
2026-05-06
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
NGETest, Luteinizing Hormone (Lh), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGETest, Luteinizing Hormone (Lh), Over The CounterClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10633472602570PackageGS16In Commercial Distribution
00633472602573PrimaryGS10
00633472000676Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063347260257010633472602570
00633472602573006334726025736334726025730633472602573
00633472000676006334720006766334720006760633472000676

GMDN Terms#

Term, Definition table
TermDefinition
Natural conception assistance kitA collection of devices intended to improve the likelihood of natural conception by monitoring ovulation and supplementing essential vitamins. The kit may contain in vitro diagnostic medical devices (IVDs) such as immunochromatographic tests for ovulation and pregnancy detection, a digital thermometer, vitamin supplements for the male and the female, and instructions for use.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
1-800-321-3279xx@xx.xx

Regulatory Flags#

DUNS number
483609579
Device count
50
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
00381519194696ClearbluePeriod Cycle Tracker- CBApp-1N/A2026-03-23
00633472600760ClearblueDigital Ovulation Test2019-04-17
00633472601156Clearblue Pregnancy Test Combo Pack2016-09-14
00633472602245ClearblueMenopause Stage IndicatorN/A2023-07-31
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 BranchNGE2026-05-08
08809408864199Surearly SMART Ovulation TestSugentech Inc._Osong BranchNGE2026-05-08
08809408864304Surearly SMART Ovulation Test Starter KitSugentech Inc._Osong BranchNGE2026-05-08
00633472602559ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
00633472602566ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
06974464591296One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
06974464591302One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
06974464591319One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
00381519194696ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-03-23
06952062712657Luteinizing Hormone (LH) Ovulation testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGE2026-03-20
06952062712671Luteinizing Hormone (LH) Ovulation testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGE2026-03-20
00075450847680Hy-Vee® Ovulation KitGuangzhou Decheng Biotechnology Co., LTDNGE2026-02-20
30075450847681Hy-Vee® Ovulation KitGuangzhou Decheng Biotechnology Co., LTDNGE2026-02-20
00045611010048SURESIGN™ Ovulation & Pregnancy Rapid TestsGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
00045611010079SURESIGN™ Digital Ovulation Rapid TestGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
50045611010074SURESIGN™ Digital Ovulation Rapid TestGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
00860015215826VivooVIVOSENS INC.NGE2026-01-19
00816862028102HORMONElife™WONDFO USA CO., LTD.NGE2025-12-15
00816862028096HORMONElife™WONDFO USA CO., LTD.NGE2025-12-15
10810174471059HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
10810174471073HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
10810174471097HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
10810174471110HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
00860014219078VivooVIVOSENS INC.NGE2025-11-28
00860014219085VivooVIVOSENS INC.NGE2025-11-28
20860011489164VivooVIVOSENS INC.NGE2025-11-28
06942598202357One Step LH Ovulation Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGE2025-10-10
06942598202364One Step LH Ovulation Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGE2025-10-10
06942598202371One Step LH Ovulation Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGE2025-10-10
00860010252352kozekozeGuangzhou Decheng Biotechnology Co., LTDNGE2025-08-29