FDA.reportPublic FDA data

Zacurate

Primary DI
00856964007322
Brand
Zacurate
Company
EINSTEIN ASSOCIATES LLC
Model
M490N-CBAA-EGZA
Catalog number
M490N-CBAA-EGZA
Device description
Zacurate Combined Pregnancy Kit - 60 Ovulation strip + 20 Pregnancy strips
Published
2018-06-29
Public version status
Update
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
00856964007322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856964007322008569640073228569640073220856964007322

GMDN Terms#

Term, Definition table
TermDefinition
Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of luteinizing hormone (LH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8329398290cs@beyondmedshop.com

Regulatory Flags#

DUNS number
080641505
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850043916000Zacurate500E PurpleM430N-DLVO-CMZA-3M2025-01-28
00850043916024Zacurate500E-BM430N-BLWH-CMZA2025-01-28
00850043916031Zacurate500B-BM430N-BBBL-LHZA2025-01-28
00850043916178VaunnvB100A-MM420N-MGWH-MLVM2025-01-28
00850043916185VaunnvB100A-LM420N-LGWH-MLVM2025-01-28
00851697006543InnovoiP900APM430N-PEWH-CMIM-42025-01-28
00851697006659InnovoiP900BP-BM430N-CBWH-CMIM2025-01-28
00856964007513Zacurate500CLM430N-ABCL-CMZA2025-01-28
00856964007698Zacurate500DL BlackM430N-AABK-CMZA2025-01-28
00856964007704Zacurate500DL PurpleM430N-AAVO-CMZA2025-01-28
00856964007728Zacurate500C BlackM430N-DCBK-CMZA2025-01-28
00856964007780Zacurate500E BlackM430N-DLBK-CMZA2025-01-28
00856964007803Zacurate500DL PinkM430N-AAPK-JPZA-M22025-01-28
00856964007810Zacurate500E PinkM430N-DLPK-CMZA-AX2025-01-28
00856964007827Zacurate500E WhiteM430N-DLWH-CMZA-42025-01-28
00856964007919Zacurate500DL-M BlackM430N-MABK-CMZA2025-01-28
00856964007964Zacurate500BLM430N-MBBL-CMZA2025-01-28
00856964007339ZacurateM491N-2WVB-EGZAM491N-2WVB-EGZA2018-06-29
00856964007001Zacurate430PM430N-PDWH-CMZA2017-06-13
00856964007018Zacurate430/DLM430N-DLWH-CMZA2017-06-13

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