FDA.reportPublic FDA data

Alinity

Primary DI
00380740155339
Brand
Alinity
Company
ABBOTT IRELAND
Model
04T9930
Catalog number
04T9930
Device description
Lactate Dehydrogenase2
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CFJNAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFJNad Reduction/Nadh Oxidation, Lactate DehydrogenaseClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740155339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740155339003807401553393807401553390380740155339

GMDN Terms#

Term, Definition table
TermDefinition
Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total lactate dehydrogenase (LDH) in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature030 Degrees Celsius
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
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
00380740155889ARCHITECT04T343004T34302024-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740155322AlinityABBOTT IRELANDCFJ2025-12-19
00380740195236ARCHITECTABBOTT IRELANDCFJ2025-12-19
00380740195243ARCHITECTABBOTT IRELANDCFJ2025-12-19
00850053916137IDG/SanzayIDG/SANZAY CorporationCFJ2024-01-12
10673486002027Teco Diagnostics LDH Liquid Reagent Kit for TC MatrixTECO DIAGNOSTICSCFJ2023-11-13
10673486002034Teco Diagnostics Lactate Dehydrogenase (LDH-L) Liquid Reagent SetTECO DIAGNOSTICSCFJ2023-11-13
10673486002041Teco Diagnostics LDH Liquid Reagent Kit for TC MatrixTECO DIAGNOSTICSCFJ2023-11-13
10673486002058Teco Diagnostics LDH Liquid Reagent Kit for TC MatrixTECO DIAGNOSTICSCFJ2023-11-13
10673486002065Teco Diagnostics LDH-L Reagent SetTECO DIAGNOSTICSCFJ2023-11-13
10673486002072Teco Diagnostics LDH-L Reagent SetTECO DIAGNOSTICSCFJ2023-11-13
06971674863267BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863274BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863281BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863298BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863304BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863311BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863328BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863335BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863342BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863359BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863366BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863373BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863380BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
00811727015891Pointe Lactate Reagent HORIBA INSTRUMENTS INCORPORATEDCFJ2021-01-30
00811727015907Pointe Lactate Dehydrogenase ReagentHORIBA INSTRUMENTS INCORPORATEDCFJ2021-01-30
00811727016195Pointe Lactic Acid ReagentHORIBA INSTRUMENTS INCORPORATEDCFJ2021-01-30
00811727016201Pointe Lactate Dehydrogenase ReagentHORIBA INSTRUMENTS INCORPORATEDCFJ2021-01-30
03610230007075Yumizen C1200 LDHHORIBA ABX SASCFJ2020-08-28
10758750031108VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CFJ2020-04-18
07613336121368Lactate Dehydrogenase acc. to IFCC ver.2Roche Diagnostics GmbHCFJ2020-03-05