Diazyme

Primary DI
00817089023048
Brand
Diazyme
Company
DIAZYME LABORATORIES, INC.
Model
DZ122A-KY1
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K060619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060619000DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122ADiazyme Laboratories2006-07-21KHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817089023048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817089023048008170890230488170890230480817089023048

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 qualitative and/or quantitative detection of carbon dioxide (CO2) in a clinical specimen, using a spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080507219
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
00817089022690DiazymeDZ558A-KY12020-07-29
00817089020900Diazyme Procalcitonin AssayDZ558A-K2017-09-01
00817089022478DiazymeDZ248A-CON2026-01-21
00817089023222Diazyme100148B-CAL2026-01-21
00817089023239Diazyme100148B-CON2026-01-21
00817089021358DiazymeDZ168C-CAL2020-07-21
00817089021365DiazymeDZ168C-CON2020-07-21
00817089021464DiazymeDZ568A-CA52020-07-21
00817089020047DiazymeDZ122A-CAL2016-11-03
00817089020054DiazymeDZ122A-CON2016-11-03
00817089020504DiazymeDZ042A-CAL2016-11-03
00817089020511DiazymeDZ042A-CON2016-11-03
00817089020535DiazymeDZ179A-CAL2016-11-03
00817089020542DiazymeDZ179A-CON2016-11-03
00817089020627DiazymeDZ147A-CAL2016-11-03
00817089020634DiazymeDZ147A-CON2016-11-03
00817089020689DiazymeDZ768A-CAL2016-11-03
00817089020696DiazymeDZ768A-CON2016-11-03
00817089020863DiazymeDZ141A-CAL2016-11-03
00817089022539DiazymeDZ152A-CON2023-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
EABA40000221Piccolo Electrolyte PanelABAXIS, INC.KHS2016-09-23