FDA.reportPublic FDA data

OPTI CCA E-Glu Cassette

Primary DI
00894472000275
Brand
OPTI CCA E-Glu Cassette
Company
OPTI MEDICAL SYSTEMS, INC.
Model
1
Catalog number
BP7564
Device description
OPTI CCA E-Glu Cassette
Published
2019-09-03
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
CGAGlucose Oxidase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131126000OPTI CCA-TS2Opti Medical Systems, Inc.2013-08-22CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894472000275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894472000275008944720002758944720002750894472000275

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
00894472000237B Cassette1BP75622019-08-07
00894472000244OPTI CCA E Cassette1BP75872019-08-07
00894472000251E-Ca Cassette Carton1BP75602019-09-03
00894472000268OPTI CCA E-Cl Cassette1BP75592019-09-03
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

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Primary DI, Brand, Company table
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00383568100826CareLiving BGM101 Blood Glucose MeterCare Living Diagnostics Inc.CGA2024-08-07
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00383568100734CareLiving MM1100 Blood Glucose Test Strips 100ctCare Living Diagnostics Inc.CGA2024-04-19
00383568100741CareLiving MM1100 Blood Glucose Test Strips 50ct Care Living Diagnostics Inc.CGA2024-04-19
00383568100819CareLiving Blood Glucose Test Strips 100ctCare Living Diagnostics Inc.CGA2023-11-15
00383568100857CareLiving Blood Glucose Test Strips 50ct Care Living Diagnostics Inc.CGA2023-11-15
00383568100710CareLiving MM1100 Blood Glucose Monitoring SystemCare Living Diagnostics Inc.CGA2023-11-14
00381932488013Assy Vial, eGLU, 13 ct.POLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-07-30
00381934755014eGLU, 15ct., CCPlus HomePOLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-06-20
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MHC19902833042Members MarkWAL-MART STORES, INC.CGA2023-05-10
MHC19902833062Members MarkWAL-MART STORES, INC.CGA2023-04-18
MHC19902833072Members MarkWAL-MART STORES, INC.CGA2023-04-18
00381934748016Assy Vial, eGLU Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-03-25
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
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10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
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10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
00353885012652OneTouch Ultra Blue Test StripsLifeScan U.S. LLCCGA2022-07-28
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