FDA.reportPublic FDA data

ACCU NEWS Pregnancy Test Midstream

Primary DI
10850042559007
Brand
ACCU NEWS Pregnancy Test Midstream
Company
CORETESTS, INC.
Model
Midstream
Device description
3 pcs/box
Published
2022-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150063000One Step hCG Pregnancy TestCoretests, Inc.2015-10-02LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850042559007PackageGS13In Commercial Distribution
00850042559000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004255900710850042559007
00850042559000008500425590008500425590000850042559000

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

Regulatory Flags#

DUNS number
036440919
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850042559765CorDx TyfastACT21012-32025-03-07
00850042559772CorDx Tyfast ACT21013 2025-03-07
00850042559826CorDx Tyfast ACT21006-72025-03-07
00850042559833CorDx Tyfast ACT21006-212025-03-07
10850042559762CorDx TyfastACT21012-32025-03-07
10850042559779CorDx Tyfast ACT21013 2025-03-07
00850042559819CorDx TyfastACT21006-32025-03-07
10850042559823CorDx Tyfast ACT21006-72025-03-07
10850042559830CorDx Tyfast ACT21006-212025-03-07
00850042559871CorDx Tyfast ACT21011-72025-03-07
00850042559888CorDx TyfastACT21014-212025-03-07
00850042559000ACCU NEWS Pregnancy Test MidstreamMidstream2022-08-31
00850042559017ACCU NEWS Ovulation Test + Pregnancy Test Combostrip2022-08-31
00850042559536CorDx TyfastACT21002-52024-06-13
00850042559550CorDx TyfastACT21002-22024-06-13
00850042559567CorDx TyfastACT21002-42024-06-13
00850042559529CorDx TyfastACT21002-12024-06-13
00850042559666CorDx TyfastACT21003-2A2024-09-05
00850042559925CorDx TyfastACT21003-52024-09-05
00850042559932CorDx TyfastACT21003-82024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00197870203805H.E.BH. E. BUTT GROCERY COMPANYLCX2025-11-28
00197870203812H.E.BH. E. BUTT GROCERY COMPANYLCX2025-11-28
00197870203843H.E.BH. E. BUTT GROCERY COMPANYLCX2025-11-12
00197870203836H.E.BH. E. BUTT GROCERY COMPANYLCX2025-11-11