FDA.reportPublic FDA data

LotFancy

Primary DI
06938444985017
Brand
LotFancy
Company
Equinox Biotech Co., Ltd.
Model
11C-1867-U
Catalog number
RH-HCG-B
Device description
LotFancy Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 25pcs of 2.5mm strips in each box.
Published
2019-06-28
Public version status
Update
Distribution status
Not 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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053236000DAVID PREGNANCY TEST (MIDSTREAM)Runbio Biotech Co.,Ltd2006-07-18LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938444985017PrimaryGS10
06938444980104Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938444985017069384449850176938444985017
06938444980104069384449801046938444980104

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure35.6 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545868502
Device count
10
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938444982801DAVIDHCG10-S012026-06-01
06938444982818DAVIDLH-S012026-06-01
00850014758431NATALIST PREGNANCY TEST STRIP 15 COUNT58431RH-HCG-S2022-01-27
00850014758042NATALIST OVULATION TEST MIDSTREAM 10 COUNT58042RH-LH-B2021-01-01
00850014758240NATALIST OVULATION TEST STRIP 30 COUNT58240RH-LH-S2021-01-01
00850014758257 NATALIST PREGNANCY TEST MIDSTREAM 2 COUNT582572021-01-01
00850014758363NATALIST8363RH-HCG-B2019-12-25
00860001730203Natalist Pregnancy Test 822142019-07-13
00860001730210Natalist Ovulation Test82221RH-LH-B2019-07-13
16938444982716ZiQ82712025-02-21
06938444982726DAVID827262025-05-19
06938444982733DAVID Ovulation Test StripstripRH-LH25-S2025-05-19
06938444981316INVBIO813162019-06-01
06938444981323INVBIO813232019-06-01
06938444982238AFAC One Step HCG and Ovulation Urine test Kit822382019-07-18
06938444982351SMILEREADER Ovulation Test Kit 823512020-06-10
06938444982641DAVID826412022-07-15
06938444982603DAVID826032022-07-01
06938444982610DAVID826102022-07-01
06938444982498OT80-Beurer Ovulation Predictor and Fertility Tracking Kit824982021-06-30

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
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
00036800028326TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028333TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028340TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028357TopCare HealthTopco Associates, LLCLCX2026-07-13
00810174470543HORMONElife™WONDFO USA CO., LTD.LCX2026-06-26
00633472602603ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHLCX2026-06-25
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