FDA.reportPublic FDA data

ADVIA® Chemistry CO2_L Reagents (Liquid)

Primary DI
00630414498928
Brand
ADVIA® Chemistry CO2_L Reagents (Liquid)
Company
Siemens Healthcare Diagnostics Inc.
Model
10327377
Catalog number
7987100
Device description
CO2 enzymatic - ADVIA Chem. - RGT - 4x600 tests
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHSENZYMATIC, CARBON-DIOXIDE

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100289000ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781Siemens Healthcare Diagnostics2010-05-10KHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414498928PrimaryGS10
00630414003634Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414498928006304144989286304144989280630414498928
00630414003634006304140036346304140036340630414003634

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
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
4
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
00630414008950ADVIA Chemistry P5PL_c Reagent10729782107297822021-11-04
00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
00630414513157ADVIA® Chemistry IRON_2 Reagents10341118103411182020-09-24
00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated10283341102833412020-09-24
00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00380740121600AlinityAbbott GmbHKHS2018-08-08
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
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