FDA.reportPublic FDA data

CLUNGENE

Primary DI
06950921302223
Brand
CLUNGENE
Company
Hangzhou Clongene Biotech Co., Ltd.
Model
WLH1001-210132
Published
2025-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NGETest, Luteinizing Hormone (Lh), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGETest, Luteinizing Hormone (Lh), Over The CounterClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06950921302223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950921302223069509213022236950921302223

GMDN Terms#

Term, Definition table
TermDefinition
Luteinizing hormone (LH) 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 luteinizing hormone (LH) 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. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
724157438
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06950921308096CLUNGENEIRSVq008-2016122026-04-11
06950921300816CLUNGENEDSDOA1h07-2008052026-03-28
06950921307594CLUNGENEDDOA1h07-2008022026-03-26
06950921307600CLUNGENEDSDOA1h07-2008062026-03-26
06950921307587CLUNGENEDDOA1h07-2008012026-03-24
06950921302070CLUNGENEDDOA1c07-2003072025-07-09
06950921302087CLUNGENEDDOA1c07-2003082025-07-09
06950921302179CLUNGENEDDOA1504-2003172025-07-09
06950921302186CLUNGENEDDOA1504-2003182025-07-09
06950921302230CLUNGENEWLH1001-2101332025-07-09
06950921302377CLUNGENEStrip2023-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06938444982818DAVIDEquinox Biotech Co., Ltd.NGE2026-06-01
08809408864113Surearly SMARTSugentech Inc._Osong BranchNGE2026-05-08
08809408864199Surearly SMART Ovulation TestSugentech Inc._Osong BranchNGE2026-05-08
08809408864304Surearly SMART Ovulation Test Starter KitSugentech Inc._Osong BranchNGE2026-05-08
00633472602559ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
00633472602566ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
00633472602573ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
06974464591296One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
06974464591302One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
06974464591319One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
00381519194696ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-03-23
06952062712657Luteinizing Hormone (LH) Ovulation testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGE2026-03-20
06952062712671Luteinizing Hormone (LH) Ovulation testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGE2026-03-20
00075450847680Hy-Vee® Ovulation KitGuangzhou Decheng Biotechnology Co., LTDNGE2026-02-20
30075450847681Hy-Vee® Ovulation KitGuangzhou Decheng Biotechnology Co., LTDNGE2026-02-20
00045611010048SURESIGN™ Ovulation & Pregnancy Rapid TestsGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
00045611010079SURESIGN™ Digital Ovulation Rapid TestGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
50045611010074SURESIGN™ Digital Ovulation Rapid TestGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
00860015215826VivooVIVOSENS INC.NGE2026-01-19
00816862028102HORMONElife™WONDFO USA CO., LTD.NGE2025-12-15
00816862028096HORMONElife™WONDFO USA CO., LTD.NGE2025-12-15
10810174471059HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
10810174471073HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
10810174471097HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
10810174471110HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
00860014219078VivooVIVOSENS INC.NGE2025-11-28
00860014219085VivooVIVOSENS INC.NGE2025-11-28
20860011489164VivooVIVOSENS INC.NGE2025-11-28
06942598202357One Step LH Ovulation Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGE2025-10-10
06942598202364One Step LH Ovulation Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGE2025-10-10