FDA.reportPublic FDA data

ACCU NEWS Ovulation Test + Pregnancy Test Combo

Primary DI
00850042559017
Brand
ACCU NEWS Ovulation Test + Pregnancy Test Combo
Company
CORETESTS, INC.
Model
strip
Device description
70 pcs/box
Published
2022-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LCXKit, Test, Pregnancy, Hcg, Over The Counter
NGETest, Luteinizing Hormone (Lh), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2
NGETest, Luteinizing Hormone (Lh), Over The CounterClinical Chemistry1

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
10850042559014PackageGS170In Commercial Distribution
00850042559017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004255901410850042559014
00850042559017008500425590178500425590170850042559017

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinicalA 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 includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
036440919
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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
00850042559949CorDx TyfastACT21003-102024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923304600193U Pregnancy TestWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-28
86950996041122Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-26
86950996013099Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-25
86950996019039Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-25
06950996006323Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-23
06950996030694Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-23
06950996067577Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-23
06974464591678One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-07-22
06974464591685One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-07-22
06923304600124FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600131FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600155FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600162FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600186FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304611175FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611182FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611199FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611236FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611274FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611281FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
00036800028326TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028333TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028340TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028357TopCare HealthTopco Associates, LLCLCX2026-07-13
06972412611690LittleBeginHangzhou Laihe Biotech Co.,Ltd.NGE2026-07-13
06972412611706LittleBeginHangzhou Laihe Biotech Co.,Ltd.NGE2026-07-13
06972412611713LittleBeginHangzhou Laihe Biotech Co.,Ltd.NGE2026-07-13
00810174470543HORMONElife™WONDFO USA CO., LTD.LCX2026-06-26
00633472602603ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHLCX2026-06-25
00050428050460CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03