FDA.reportPublic FDA data

Zacurate

Primary DI
00856964007339
Brand
Zacurate
Company
EINSTEIN ASSOCIATES LLC
Model
M491N-2WVB-EGZA
Catalog number
M491N-2WVB-EGZA
Device description
Zacurate Pregnancy Kit - 2pc Wand
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
LCXKit, Test, Pregnancy, Hcg, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856964007339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856964007339008569640073398569640073390856964007339

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, 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
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
00856964007322ZacurateM490N-CBAA-EGZAM490N-CBAA-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
00050428050460CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428082102CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428087268CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428087589CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428049556CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-02
06938444982801DAVIDEquinox Biotech Co., Ltd.LCX2026-06-01
00049696240482VeriQuickFOURSTAR GROUP INC.LCX2026-04-13
00072036734280Harris TeeterHarris Teeter, LLCLCX2026-02-27
00072036734297Harris TeeterHarris Teeter, LLCLCX2026-02-27
00075450847635Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847666Hy-Vee® Analog Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847673Hy-Vee® Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00195515147545AmazonAMAZON.COM SERVICES LLCLCX2026-02-20
00195515147552AmazonAMAZON.COM SERVICES LLCLCX2026-02-20
00311917083803WalgreensWALGREEN CO.LCX2026-02-17
00311917083957WalgreensWALGREEN CO.LCX2026-02-17
00311917084022WalgreensWALGREEN CO.LCX2026-02-17
00070552251137Winco Foods One Step Pregnancy TestWINCO FOODS, LLCLCX2026-02-09
00311917083452WalgreensWALGREEN CO.LCX2026-02-05
00311917083513WalgreensWALGREEN CO.LCX2026-02-05
00311917083575WalgreensWALGREEN CO.LCX2026-02-05
00045611010000SURESIGN™ Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010017SURESIGN™ Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010024SURESIGN™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010031SURESIGN™ Early Detection Pregnancy Test + Digital Pregancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010048SURESIGN™ Ovulation & Pregnancy Rapid TestsGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
10810174471059HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05
10810174471073HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05
10810174471097HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05
10810174471110HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05