Home GUDID 00850042559017 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 Code Name LCX Kit, Test, Pregnancy, Hcg, Over The Counter NGE Test, Luteinizing Hormone (Lh), Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry 2 NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850042559014 Package GS1 70 In Commercial Distribution 00850042559017 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10850042559014 10850042559014 00850042559017 00850042559017 850042559017 0850042559017
GMDN Terms# Term, Definition table Term Definition Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical A 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 50045611956013 ept Pregnancy (hCG) Enhanced Sensitivity Rapid Test Midstream (Urine) Hangzhou AllTest Biotech Co., Ltd. LCX 2026-10-29 50045611956044 ept Digital Early Pregnancy Test Midstream(Urine) Hangzhou AllTest Biotech Co., Ltd. LCX 2026-10-29 00022600230021 First Response™ Daily Check Pregnancy Test Kit CHURCH & DWIGHT CO., INC. LCX 2026-10-28 00045611956049 ept Digital Early Pregnancy Test Midstream(Urine) Hangzhou AllTest Biotech Co., Ltd. LCX 2026-10-27 06978151200195 HCG One Step Pregnancy Test Midstream OTC Hangzhou Aichek Medical Technology Co., Ltd. LCX 2026-10-27 00045611951013 ept Pregnancy (hCG) Rapid Test Midstream (Urine) Hangzhou AllTest Biotech Co., Ltd. LCX 2026-10-26 06978151200201 HCG One Step Pregnancy Test Strip OTC Hangzhou Aichek Medical Technology Co., Ltd. LCX 2026-10-23 10850078377378 iHealth iHealth Labs Inc. LCX 2026-10-22 00808829132373 PERSONAL CARE DELTA BRANDS INC. NGE 2026-10-16 00846036009910 Goodsense GEISS, DESTIN & DUNN, INC LCX 2026-10-13 00311917090498 Walgreens WALGREEN CO. LCX 2026-10-12 06923304600193 U Pregnancy Test Weihai Kangzhou Biotechnology Engineering Co., Ltd LCX 2026-07-28 86950996041122 Orient Gene Zhejiang Orient Gene Biotech Co.,Ltd. LCX 2026-07-26 86950996013099 Orient Gene Zhejiang Orient Gene Biotech Co.,Ltd. LCX 2026-07-25 86950996019039 Orient Gene Zhejiang Orient Gene Biotech Co.,Ltd. LCX 2026-07-25 06950996006323 Orient Gene Zhejiang Orient Gene Biotech Co.,Ltd. LCX 2026-07-23 06950996030694 Orient Gene Zhejiang Orient Gene Biotech Co.,Ltd. LCX 2026-07-23 06950996067577 Orient Gene Zhejiang Orient Gene Biotech Co.,Ltd. LCX 2026-07-23 06974464591678 One Step® LH Ovulation Rapid Test Dipstick (Urine) Guangzhou Decheng Biotechnology Co., LTD NGE 2026-07-22 06974464591685 One Step® LH Ovulation Rapid Test Dipstick (Urine) Guangzhou Decheng Biotechnology Co., LTD NGE 2026-07-22 06923304600124 FERTICARE Weihai Kangzhou Biotechnology Engineering Co., Ltd LCX 2026-07-21 06923304600131 FERTICARE Weihai Kangzhou Biotechnology Engineering Co., Ltd LCX 2026-07-21 06923304600155 FERTICARE Weihai Kangzhou Biotechnology Engineering Co., Ltd LCX 2026-07-21 06923304600162 FERTICARE Weihai Kangzhou Biotechnology Engineering Co., Ltd LCX 2026-07-21 06923304600186 FERTICARE Weihai Kangzhou Biotechnology Engineering Co., Ltd LCX 2026-07-21 06923304611175 FERTICARE Weihai Kangzhou Biotechnology Engineering Co., Ltd NGE 2026-07-21 06923304611182 FERTICARE Weihai Kangzhou Biotechnology Engineering Co., Ltd NGE 2026-07-21 06923304611199 FERTICARE Weihai Kangzhou Biotechnology Engineering Co., Ltd NGE 2026-07-21 06923304611236 FERTICARE Weihai Kangzhou Biotechnology Engineering Co., Ltd NGE 2026-07-21 06923304611274 FERTICARE Weihai Kangzhou Biotechnology Engineering Co., Ltd NGE 2026-07-21