FDA.reportPublic FDA data

Accu-Clear

Primary DI
00633472601958
Brand
Accu-Clear
Company
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
Model
OVULATION TEST
Device description
AccuClear Ovul Strip 50ct US
Published
2020-11-11
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
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
10633472601955PackageGS160Not in Commercial Distribution
00633472601958PrimaryGS10
00633472000393Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063347260195510633472601955
00633472601958006334726019586334726019580633472601958
00633472000393006334720003936334720003930633472000393

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
1-888-698-5031xx@xx.xx

Regulatory Flags#

DUNS number
004238200
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
00047400703117Braun Silk.expert Pro 5PL51002026-01-05
00047400703230Braun Silk.expert Pro 5PL54422026-01-05
00047400703360Braun Skin i-expertPL72192026-01-05
10047400703114Braun Silk.expert Pro 5PL51002026-01-05
10047400703237Braun Silk.expert Pro 5PL54422026-01-05
10047400703367Braun Skin i-expertPL72192026-01-05
00073010720749TampaxTampax Pearl2025-12-19
00073010720756TampaxTampax Pearl2025-12-19
00073010721043TampaxTampax Pearl2025-12-19
00073010721050TampaxTampax Pearl2025-12-19
00073010721104TampaxTampax Pearl2025-12-19
00073010721319L.This is L. Tampon2025-12-19
00073010721326L.This is L. Tampon2025-12-19
40073010720747TampaxTampax Pearl2025-12-19
20073010720750TampaxTampax Pearl2025-12-19
10073010721040TampaxTampax Pearl2025-12-19
40073010721058TampaxTampax Pearl2025-12-19
40073010721263TampaxTampax Pearl2025-12-19
10073010721316L.This is L. Tampon2025-12-19
10073010721323L.This is L. Tampon2025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06938444982818DAVIDEquinox Biotech Co., Ltd.NGE2026-06-01
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
00633472602573ClearblueSPD 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