FDA.reportPublic FDA data

Alinity

Primary DI
00380740121600
Brand
Alinity
Company
Abbott GmbH
Model
07P7230
Catalog number
07P7230
Device description
Alinity c Carbon Dioxide Reagent Kit 15000 Tests
Published
2018-08-08
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
KHSENZYMATIC, CARBON-DIOXIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHSEnzymatic, Carbon-DioxideClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740121600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740121600003807401216003807401216000380740121600

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide (CO2) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of carbon dioxide (CO2) in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature030 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
315786293
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817089023048DiazymeDIAZYME LABORATORIES, INC.KHS2026-01-21
10673486001624Teco Diagnostics Carbon Dioxide (CO2) Reagent SetTECO DIAGNOSTICSKHS2023-07-25
00811727016102Pointe Carbon Dioxide ReagentHORIBA INSTRUMENTS INCORPORATEDKHS2021-01-30
03610230006863Yumizen C1200 CO2HORIBA ABX SASKHS2020-08-28
00811727015792Pointe Carbon Dioxide on the BS480HORIBA INSTRUMENTS INCORPORATEDKHS2020-05-28
07613336121146Bicarbonate LiquidRoche Diagnostics GmbHKHS2020-03-05
00380740161545ARCHITECTAbbott GmbHKHS2020-01-25
00380740161521ARCHITECTAbbott GmbHKHS2020-01-04
00380740161538ARCHITECTAbbott GmbHKHS2020-01-04
00386100002053CO2 Reagent Kit MEDICA CORPORATIONKHS2019-02-14
00380740121594AlinityAbbott GmbHKHS2018-08-31
00852169008072ClearChem Diagnostics Inc. Carbon Dioxide (CO2)CLEARCHEM DIAGNOSTICS INC.KHS2018-04-30
00630414595900Atellica CH CO2_cSiemens Healthcare Diagnostics Inc.KHS2017-12-22
00845275000047Thermo Scientific Infinity™Fisher DiagnosticsKHS2017-06-22
00630414000541ADVIA Chemistry CO2_cSiemens Healthcare Diagnostics Inc.KHS2017-05-01
00817274022498JAS DiagnosticsDREW SCIENTIFIC, INC.KHS2017-04-10
00817089020047DiazymeDIAZYME LABORATORIES, INC.KHS2016-11-03
00817089020054DiazymeDIAZYME LABORATORIES, INC.KHS2016-11-03
00817302022988CAROLINA LIQUID CHEMISTRIES CORP.® CO2 REAGENT PRODUCT NO. DT313CAROLINA LIQUID CHEMISTRIES CORPORATIONKHS2016-10-17
00812137011947Carbon Dioxide ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.KHS2016-10-12
15099590010348AUBeckman Coulter, Inc.KHS2016-09-24
15099590020187AUBeckman Coulter, Inc.KHS2016-09-24
15099590060206AUBeckman Coulter, Inc.KHS2016-09-24
00842768005374Dimension® Flex® reagent cartridge EC02Siemens Healthcare Diagnostics Inc.KHS2016-09-24
00842768015625Dimension Vista® Flex® reagent cartridge CO2Siemens Healthcare Diagnostics Inc.KHS2016-09-24
00857969006150ACEALFA WASSERMANN, INC.KHS2016-09-24
00630414498928ADVIA® Chemistry CO2_L Reagents (Liquid)Siemens Healthcare Diagnostics Inc.KHS2016-09-24
00630414505497ADVIA® Chemistry CO2_L Carbon Dioxide Liquid ReagentsSiemens Healthcare Diagnostics Inc.KHS2016-09-24
00630414553177ADVIA® Chemistry CO2_c Reagents ConcentratedSiemens Healthcare Diagnostics Inc.KHS2016-09-24
EABA40000221Piccolo Electrolyte PanelABAXIS, INC.KHS2016-09-23