FDA.reportPublic FDA data

Teco Diagnostics Carbon Dioxide (CO2) Reagent Set

Primary DI
10673486001624
Brand
Teco Diagnostics Carbon Dioxide (CO2) Reagent Set
Company
TECO DIAGNOSTICS
Model
C525-60
Catalog number
C525-60
Device description
Teco Diagnostics Carbon Dioxide (CO2) Reagent Set is used for manual or automated quantitative determination of carbon dioxide content in human plasma or serum at 340 nm.
Published
2023-07-25
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942735000CARBON DIOXIDE (C02)Teco Diagnostics1995-03-20KHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486001624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600162410673486001624

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide (CO2) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of bicarbonate (HCO3-) ions [as a measure of carbon dioxide (CO2) concentration] in a clinical specimen.

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
714-463-1111hello@tecodiagnostics.com

Regulatory Flags#

DUNS number
185067774
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MatrixTC-Matrix2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MATRIX-160TC-MATRIX-1602025-05-28
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10673486000726Teco Diagnostics Glucopad Blood Glucose Test StripsGlucopad Blood Glucose Test StripsG852-B-0022024-12-19
10673486002454Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestP596-25P596-252024-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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
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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
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15099590010348AUBeckman Coulter, Inc.KHS2016-09-24
15099590020187AUBeckman Coulter, Inc.KHS2016-09-24
15099590060206AUBeckman Coulter, Inc.KHS2016-09-24
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00857969006150ACEALFA WASSERMANN, INC.KHS2016-09-24
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00630414553177ADVIA® Chemistry CO2_c Reagents ConcentratedSiemens Healthcare Diagnostics Inc.KHS2016-09-24
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