FDA.reportPublic FDA data

GENCHEM™ Glucose Oxidase Reagent

Primary DI
00851445007228
Brand
GENCHEM™ Glucose Oxidase Reagent
Company
GENCHEM INC
Model
GEN-GLU LX
Catalog number
GEN-GLU LX
Device description
10/17/2022
Published
2016-09-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K040974000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040974000GLUCOSE OXIDASE, GLUCOSEGenchem, Inc.2004-12-27CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851445007228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851445007228008514450072288514450072280851445007228

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714)529-7125lorlow@genchem.org

Regulatory Flags#

DUNS number
193856866
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851445007006GENCHEM™ Albumin ReagentGEN-ALBGEN-ALB2016-09-19
00851445007013GENCHEM™ Albumin ReagentGEN-ALB-GGEN-ALB-G2016-09-19
00851445007020GENCHEM™ Alkaline PhosphataseGEN-ALP R1GEN-ALP R12016-09-19
00851445007037GENCHEM™ Alkaline PhosphataseGEN-ALP R2GEN-ALP R22016-09-19
00851445007044GENCHEM™ Amylase ReagentGEN-AMYGEN-AMY2016-09-19
00851445007099GENCHEM™Calcium, Azo Dye ReagentGEN-CA3GEN-CA32016-09-19
00851445007211GENCHEM™ Glucose Oxidase ReagentGEN-GLU3GEN-GLU32016-09-19
00851445007235GENCHEM™ Glucose ReagentGEN-GLU4GEN-GLU42016-09-19
00851445007051GENCHEM™ AST/SGOTGEN-AST R1GEN-AST R12016-09-19
00851445007068GENCHEM™Electrode, Ion Specific, Urea Nitrogen (BUN) reagentGEN-BUN LXGEN-BUN LX2016-09-19
00851445007075GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagentGEN-BUN3GEN-BUN32016-09-19
00851445007082GENCHEM™ UREAGEN-BUN R1GEN-BUN R12016-09-19
00851445007105GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 1GEN-CAL 1GEN-CAL 12016-09-19
00851445007112GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 2GEN-CAL 2GEN-CAL 22016-09-19
00851445007129GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 3GEN-CAL 3GEN-CAL 32016-09-19
00851445007136GENCHEM™ CK-NAC ReagentGEN-CK R1GEN-CK R12016-09-19
00851445007143GENCHEM™ CK-NAC ReagentGEN-CK R2GEN-CK R22016-09-19
00851445007150GENCHEM™ CO2 Acid ReagentGEN-CO2ACIDGEN-CO2ACID2016-09-19
00851445007167GENCHEM™ CO2 Acid ReagentGEN-CO2ALKGEN-CO2ALK2016-09-19
00851445007174GENCHEM™ Creatinine Test ReagentGEN-CREA R1(Base)GEN-CREA R1(Base)2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
MHC1101665142EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
MHC18073002EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
00311917064635WalgreensWALGREEN CO.CGA2025-06-20
00353885013000OneTouch UltraLifeScan U.S. LLCCGA2025-06-20
00194346219254ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00194346219261ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00383568100826CareLiving BGM101 Blood Glucose MeterCare Living Diagnostics Inc.CGA2024-08-07
00384840105003Prodigy No Coding Blood Glucose Test StripsProdigy Diabetes Care, LLCCGA2024-07-11
00384840104006Prodigy No Coding Blood Glucose Test StripsProdigy Diabetes Care, LLCCGA2024-07-10
00054749005710i-STAT G CartridgeABBOTT POINT OF CARE INC.CGA2024-04-30
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
00381934752013Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk)POLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-06-01
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
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
00353885012652OneTouch Ultra Blue Test StripsLifeScan U.S. LLCCGA2022-07-28
00381934750019CardioChek Plus Home Self-Test AnalyzerPOLYMER TECHNOLOGY SYSTEMS, INC.CGA2022-04-11
MHC18490502BluLinkMHC MEDICAL PRODUCTS, LLCCGA2021-05-12