FDA.reportPublic FDA data

YSI Incorporated

Primary DI
00851683007257
Brand
YSI Incorporated
Company
YSI INCORPORATED
Model
2327C
Catalog number
014692
Device description
YSI 2327C LACTATE STD,5.0 MMOL/L
Published
2026-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851683007257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851683007257008516830072578516830072570851683007257

GMDN Terms#

Term, Definition table
TermDefinition
Lactate IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of lactate in a clinical specimen.

Regulatory Flags#

DUNS number
004246716
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851683007233YSI Incorporated1530C0146902026-04-28
00851683007240YSI Incorporated1531C0146912026-04-28
00851683007264YSI Incorporated2328C0146932026-04-28
00851683007271YSI Incorporated2356C0146942026-04-28
00851683007288YSI Incorporated2747C0146952026-04-28
00851683007295YSI Incorporated2367C0146962026-04-28
00851683007301YSI Incorporated2368C0146972026-04-28
00851683007318YSI Incorporated2392C0146982026-04-28
00851683007325YSI Incorporated2357C0146992026-04-28
00851683007332YSI Incorporated2365C0147002026-04-28
00851683007349YSI Incorporated2329C0147012026-04-28
00851683007356YSI Incorporated2363C0147022026-04-28
00851683007226YSI Incorporated2900C6329002026-04-27
00851683007165YSI Incorporated23570980052016-12-31
00851683007158YSI Incorporated15150150982016-12-31
00851683007196YSI Incorporated23150023152016-12-31
00851683007004YSI Incorporated27470618272016-09-26
00851683007011YSI Incorporated23920697582016-12-31
00851683007028YSI Incorporated23680980902016-09-26
00851683007035YSI Incorporated23670980892016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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