FDA.reportPublic FDA data

OPTI CCA E Cassette

Primary DI
00894472000244
Brand
OPTI CCA E Cassette
Company
OPTI MEDICAL SYSTEMS, INC.
Model
1
Catalog number
BP7587
Device description
OPTI CCA E Cassette
Published
2019-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CEMElectrode, Ion Specific, Potassium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974784000AVL OPTI CRITICAL CARE ANALYZERAvl Scientific Corp.1998-02-24CEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894472000244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894472000244008944720002448944720002440894472000244

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry enzyme IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801458279
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894472000237B Cassette1BP75622019-08-07
00894472000251E-Ca Cassette Carton1BP75602019-09-03
00894472000268OPTI CCA E-Cl Cassette1BP75592019-09-03
00894472000275OPTI CCA E-Glu Cassette1BP75642019-09-03
00894472000107OPTI Check Control Tri Level1HC70082019-08-06
00894472000114OPTI Check Plus1HC70092019-08-06
00894472000152OPTI Analyzer CCA TS 1GD70132019-08-07
00894472000176Comfort Sampler, Basic Kit1BP06102019-08-07
00894472000183Comfort Sampler Bulk1BP06202019-08-07
00894472000077OPTI Accessory Kit1GD70452019-08-06
00894472000138Comfort Sampler1BP06002019-08-06
00894472000145OPTI CCA TS Accessory Kit1BP70352019-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740215712AlinityABBOTT LABORATORIESCEM2025-10-08
10054749005519i-STATABBOTT POINT OF CARE INC.CEM2020-05-01
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.CEM2020-04-15
00380740156855ARCHITECTABBOTT LABORATORIESCEM2019-10-31
00380740163372ARCHITECTAbbott GmbHCEM2019-08-15
00386100002282ISE Reagent PackMEDICA CORPORATIONCEM2019-02-14
00386100004378EasyRA Analyzer (LIS)MEDICA CORPORATIONCEM2019-02-14
00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONCEM2019-02-14
00386100001650ISE Disposable Reference Electrode MEDICA CORPORATIONCEM2018-12-11
00386100002503Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-11
00386100002541EasyElectrolyte Reagent Module, Na/K/Cl AnalyzersMEDICA CORPORATIONCEM2018-12-11
00386100002558EasyElectrolyte Reagent Module, Na/K/Li AnalyzersMEDICA CORPORATIONCEM2018-12-11
00386100002794ISE Cleaning Solution KitMEDICA CORPORATIONCEM2018-12-11
00386100002817ISE Reagent PackMEDICA CORPORATIONCEM2018-12-11
00386100002831ISE Reagent ModuleMEDICA CORPORATIONCEM2018-12-11
00386100003524Na/K/Li AnalyzerMEDICA CORPORATIONCEM2018-12-11
00386100002596pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100002633Bi-Level QC Kit, HCTMEDICA CORPORATIONCEM2018-12-05
00386100002664Reagent ModuleMEDICA CORPORATIONCEM2018-12-05
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100003739pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100002879Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002886Lithium Na/K/Li AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002893Calcium Na/K/Ca/pH AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002909Na/K/Cl/Li AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONCEM2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONCEM2018-12-04
00386100003043Na/K/Cl Solution PackMEDICA CORPORATIONCEM2018-12-04
00386100003067Na/K/Ca/pH Solution Pack MEDICA CORPORATIONCEM2018-12-04
00386100003074Na/K/Li Solution PackMEDICA CORPORATIONCEM2018-12-04