FDA.reportPublic FDA data

ADVIA® Chemistry CO2_c Reagents Concentrated

Primary DI
00630414553177
Brand
ADVIA® Chemistry CO2_c Reagents Concentrated
Company
Siemens Healthcare Diagnostics Inc.
Model
10283345
Catalog number
6860507
Device description
CO2 enzymatic - ADVIA Chem. - Conc. RGT - 7520 tests
Published
2016-09-24
Public version status
Update
Distribution status
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
00630414553177PrimaryGS10
00630414002958Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414553177006304145531776304145531770630414553177
00630414002958006304140029586304140029580630414002958

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

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Primary DI, Brand, Company table
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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
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15099590010348AUBeckman Coulter, Inc.KHS2016-09-24
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