FDA.reportPublic FDA data

Pregmate 50 Ovulation and 20 Pregnancy Test Strips

Primary DI
00850009763150
Brand
Pregmate 50 Ovulation and 20 Pregnancy Test Strips
Company
Pregmate LLC
Model
50LH20HCG
Published
2023-04-03
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850009763150PrimaryGS10
00850009763266Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850009763150008500097631508500097631500850009763150
00850009763266008500097632668500097632660850009763266

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or 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 using an enzyme immunoassay (EIA) method. It is used to aid detection of pregnancy, or as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome).

Regulatory Flags#

DUNS number
071197287
Device count
70
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850009763068Pregmate Pregnancy Test Strips (25 Count)25HCG2023-08-16
00850009763075Pregmate Pregnancy Test Strips (50 Count)50HCG2023-08-16
00850009763082Pregmate Pregnancy Test Strips (50 Count)100HCG2023-08-16
00850009763259Pregmate Pregnancy Test Strips (50 Count)100HCG2023-08-16
00850009763280Pregmate Ovulation Test Strips (50 Count)50LH2023-08-09
00857747008932Pregmate Ovulation Test Strips (25 Count)25LH2023-08-09
00850009763273Pregmate Ovulation Test Strips (100 Count)100LH2023-07-11
00850009763167Pregmate Pregnancy Test Strips (50 Count)50HCG2023-04-03
00850009763143Pregmate Ovulation Test Strips (100 Count)100LH2023-05-08
00850009763136Pregmate Ovulation Test Strips (50 Count)50LH2023-04-03
00850009763266Pregmate 50 Ovulation and 20 Pregnancy Test Strips50LH20HCG2023-04-03

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
06974464591654One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-07-15
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