FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740003937
Brand
ARCHITECT
Company
ABBOTT IRELAND
Model
2P40-35
Catalog number
02P4035
Device description
ARCHITECT LH Reagent Kit (500T)
Published
2018-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00380740003937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740003937003807400039373807400039370380740003937

GMDN Terms#

Term, Definition table
TermDefinition
Luteinizing hormone (LH) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of luteinizing hormone (LH) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
989964119
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740180713Alinity04U002004U00202025-10-24
00380740180720ARCHITECT04T042004T04202025-10-24
00380740204020ARCHITECT04T040104T04012025-10-24
00380740204037Alinity04U000104U00012025-10-24
00380740130572Alinity07P944007P94402020-07-03
00380740014346ARCHITECT7K64-5007K64502016-09-09
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155490ARCHITECT04U453004U45302024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15

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
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
06925912718925iFlash-LHShenzhen YHLO Biotech Co., Ltd.CEP2022-10-26
00036800493919Topcare Topco Associates, LLCCEP2022-03-07