FDA.reportPublic FDA data

Sirrus® Bicarbonate (CO2) LiquiColor®

Primary DI
00657498001479
Brand
Sirrus® Bicarbonate (CO2) LiquiColor®
Company
STANBIO LABORATORY, L.P.
Model
S0190-750
Catalog number
S0190-750
Device description
For the Quantitative Determination of Bicarbonate (CO2) in Serum and Plasma.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00657498001479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498001479006574980014796574980014790657498001479

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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00657498001950Procalcitonin LiquiColor2300-0602300-0602017-06-26
00657498000434Albumin LiquiColor®0285-5000285-5002016-09-23
00657498001516Sirrus® Albumin LiquiColor®S0285-750S0285-7502016-09-23
00657498000847Glycated Serum Protein (GSP) LiquiColor®2350-0622350-0622016-09-23
00657498002179STAT-Site WB Dual Analyte Measurement System7000-0017000-0012019-11-18
00657498002193STAT-Site WB Blood Glucose Test Strips7010-0257010-0252019-11-18
00657498002209STAT-Site WB Blood Glucose Test Strips7010-0507010-0502019-11-18
00657498002216STAT-Site WB Blood Glucose Test Strips7010-1007010-1002019-11-18
00657498002230STAT-Site WB B-Ketone Test Strips7020-0257020-0252019-11-18
00657498002247STAT-Site WB B-Ketone Test Strips7020-0507020-0502019-11-18
00657498002254STAT-Site WB B-Ketone Test Strips7020-1007020-1002019-11-18
00657498002261Blood Glucose Control Solution7014-2047014-2042019-11-18
00657498002278B-Ketone Control Solution7024-2047024-2042019-11-18
00657498000427Acetaminophen Liquicolor®2400-0602400-0602016-09-23
00657498000441Alkaline Phosphatase LiquiColor®2900-4302900-4302016-09-23
00657498000458Alkaline Phosphatase LiquiColor®2900-5002900-5002016-09-23
00657498000489a-Amylase LiquiColor®2970-4302970-4302016-09-23
00657498000496AST/SGOT Liqui-UV®2920-4302920-4302016-09-23
00657498000502AST/SGOT Liqui-UV®2920-5002920-5002016-09-23
00657498000519B-Hydroxybutyrate LiquiColor®2440-0582440-0582016-09-23

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
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
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