FDA.reportPublic FDA data

iFlash-LH

Primary DI
06925912718925
Brand
iFlash-LH
Company
Shenzhen YHLO Biotech Co., Ltd.
Model
C86010
Published
2022-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CEPRadioimmunoassay, Luteinizing Hormone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEPRadioimmunoassay, Luteinizing HormoneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06925912718925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06925912718925069259127189256925912718925

GMDN Terms#

Term, Definition table
TermDefinition
Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of luteinizing hormone (LH) in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420735989
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
06925912718512iFlash-T4C860262022-10-26
06925912718703iFlash-HCGC860122024-01-30
06925912718833iFlash-Anti-Beta2-Glycoprotein IC89027Z2023-12-31
06925912710424Chemiluminescence Immunoassay AnalyzeriFlash 3000-CC61112022-10-26
06925912710547Chemiluminescence Immunoassay AnalyzeriFlash 3000-CC61062022-10-26
06925912719205iFlash-Mycoplasma pn. IgMC88004M2022-10-26
06925912715290iFlash-Cleaning SolutionC899232022-10-26
06925912716044Wash BufferC800012022-10-26
06925912716075Trigger Solution (1×)C899982022-10-26
06925912716099Trigger Solution (1×)C899482022-10-26
06925912716105Pre-Trigger Solution (1×)C899992022-10-26
06925912716112Pre-Trigger Solution (1×)C899592022-10-26
06925912716129Pre-Trigger Solution (1×)C899492022-10-26
06925912716587Sample DiluentC899112022-10-26
06925912716600Sample DiluentC899122022-10-26
06925912716624Sample DiluentC899142022-10-26
06925912716631Sample DiluentC899152022-10-26
06925912716648Sample DiluentC899172022-10-26
06925912716679Sample DiluentC899182022-10-26
06925912716693Sample DiluentC899192022-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970429844124FloCo-Innovation Biotech Co., LtdCEP2026-03-31
07613336218402Elecsys LHRoche Diagnostics GmbHCEP2026-02-19
00850054026712AccuDiag™ LH ELISADiagnostic Automation, Inc.CEP2026-01-30
10850049545492QMedix™Diagnostic Automation, Inc.CEP2025-12-24
00850049545495QMedix™Diagnostic Automation, Inc.CEP2025-12-24
06923304611144Sims ovulation test kitWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2025-12-03
06970429844117co-innovationCo-Innovation Biotech Co., LtdCEP2025-10-20
14562185399711CL AIA-PACK LH TEST CUPTOSOH CORPORATIONCEP2025-09-01
24562185399718CL AIA-PACK LH TEST CUPTOSOH CORPORATIONCEP2025-09-01
04048474012897LH-Serum ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2024-11-22
04048474012903LH-Urine ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2024-11-22
15099590575243Access hLHBeckman Coulter, Inc.CEP2024-04-23
06923304611120FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2024-01-11
06923304611137FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2024-01-11
00050428296646CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDCEP2023-10-25
10050428296643CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDCEP2023-10-25
04048474053623LHDRG Instruments Gesellschaft mit beschränkter HaftungCEP2023-09-01
04048474041033LH ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2023-08-31
00840239053626LHDRG International IncCEP2023-08-26
00840239012890LH-Serum ELISADRG International IncCEP2023-08-22
00840239012906LH-Urine ELISADRG International IncCEP2023-08-22
06923304611113INSTANT Aid By PUR-estWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2023-08-15
15099590232276Access hLH CalibratorBeckman Coulter, Inc.CEP2023-06-26
00810038634036Easy@Home Ovulation Test Kit (25 LH strips + 10 HCG strips)EASY HEALTHCARE CORPORATIONCEP2023-01-11
00810038634050Easy@Home Ovulation Test Kit (15 LH strips + 5 HCG strips ) EASY HEALTHCARE CORPORATIONCEP2023-01-11
00810038634586Easy@Home Ovulation Test Kit (20 LH strips + 5 HCG strips ) EASY HEALTHCARE CORPORATIONCEP2023-01-11
00810038633787Easy@Home Ovulation Test Kit (30 LH strips+30 Cups)EASY HEALTHCARE CORPORATIONCEP2023-01-09
00810038634029Easy@Home Ovulation Test Kit (40 LH strips + 10 HCG strips + 50 Cups )EASY HEALTHCARE CORPORATIONCEP2023-01-09
00810038634487Easy@Home Ovulation Test Kit (25 LH strips + 10 HCG strips + 40 Cups ) EASY HEALTHCARE CORPORATIONCEP2023-01-09
B261CANLH40400DBC Luteinizing Hormone (LH) ELISADiagnostics Biochem Canada IncCEP2022-11-15