FDA.reportPublic FDA data

B Cassette

Primary DI
00894472000237
Brand
B Cassette
Company
OPTI MEDICAL SYSTEMS, INC.
Model
1
Catalog number
BP7562
Device description
B Cassette Carton
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
GKRSystem, Hemoglobin, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKRSystem, Hemoglobin, AutomatedHematology2

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
00894472000237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894472000237008944720002378944720002370894472000237

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894472000244OPTI CCA E Cassette1BP75872019-08-07
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
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSGKR2024-07-01
04048534000840CleanerEKF-diagnostic GmbHGKR2022-12-21
04048534002189Add Pack Hemo Control DMEKF-diagnostic GmbHGKR2022-12-21
04048534001540DiaSpect Hemoglobin CuvettesDiaSpect Medical GmbHGKR2022-12-20
17311091118148HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-10-28
27311091118077HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-10-28
04048534002165DiaSpect TmEKF-diagnostic GmbHGKR2022-10-17
17311091118124HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-08-30
27311091118121HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-08-30
04048534000031Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2021-05-10
04048534002035Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2021-05-10
04048534002028Hemo ControlEKF-diagnostic GmbHGKR2021-05-10
14048534001967DiaSpect Tm CuvettesEKF-diagnostic GmbHGKR2021-03-11
04048534001946DiaSpect TmEKF-diagnostic GmbHGKR2021-03-11
24048534001964DiaSpect Tm CuvettesEKF-diagnostic GmbHGKR2021-03-11
17311091118094HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2020-09-04
07311091218278HemoCue® Hb301 AnalyzerHemocue ABGKR2020-09-04
07311091118097HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2020-09-04
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.GKR2020-04-15
10722355003020hemochroma PLUS MicrocuvettesImmunostics Company, IncGKR2018-12-20
10722355003044hemochroma PLUS Optical System CheckImmunostics Company, IncGKR2018-12-20
10722355003013hemochroma PLUS AnalyzerImmunostics Company, IncGKR2018-12-20
10722355003051hemochroma PLUS Starter KitImmunostics Company, IncGKR2018-12-20
05700699059178REF 905-917 ABL90 FLEX sBOXRadiometer Medical ApSGKR2018-09-21
05700699059185905-918 ABL90 FLEX flush deviceRadiometer Medical ApSGKR2018-09-21
05700699059567REF 905-956 ABL90 FLEX sBOX PLUSRadiometer Medical ApSGKR2018-09-21
10612479234090McKessonMCKESSON MEDICAL-SURGICAL INC.GKR2018-08-21
10612479234120McKessonMCKESSON MEDICAL-SURGICAL INC.GKR2018-08-21
10612479234144McKessonMCKESSON MEDICAL-SURGICAL INC.GKR2018-08-21
17311091117318HemoCue® Hb 201 MicrocuvettesHemocue ABGKR2018-05-25