FDA.reportPublic FDA data

Assy Vial, eGLU, 13 ct.

Primary DI
10381932488010
Brand
Assy Vial, eGLU, 13 ct.
Company
POLYMER TECHNOLOGY SYSTEMS, INC.
Model
REF 2488
Catalog number
REF 2488
Device description
The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human whole blood from the fingertip. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer.
Published
2023-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00381932488013PrimaryGS10
10381932488010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381932488013003819324880133819324880130381932488013
1038193248801010381932488010

GMDN Terms#

Term, Definition table
TermDefinition
Multiple lipid analyte IVD, kit, multiple technologiesA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to produce a lipid profile, using a number of different technologies on a single analyser. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight Keep dry
Storage Environment Temperature20 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)870-5610customerservice@ptsdiagnostics.com

Regulatory Flags#

DUNS number
835772872
Device count
13
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00381931716018PTS Panels® Triglycerides Test Strips171617162016-07-22
00381934770017CholesterolREF 477047702025-06-16
00381934774015PTS Diagnostics Capillary TubesREF 477447742025-06-16
10381934770014CholesterolREF 477047702025-06-16
10381934774012PTS Diagnostics Capillary TubesREF 477447742025-06-16
00381933080018A1CNow Self Check, 8ct.308030802023-10-25
10381933080015A1CNow Self Check, 8ct.308030802023-10-25
00381934750019CardioChek Plus Home Self-Test Analyzer475047502022-04-11
00381934720012CardioChek Plus Home Self-Test Analyzer472047202021-02-08
00381931708013CardioChek® PA analyzer170817082016-07-15
00381931709010CardioChek® Analyzer170917092016-07-15
00381931757011CardioChek® PA Professional Analyzer, Refurbished175717572016-07-15
00381931782013CardioChek® Analyzer; Refurbished178217822016-07-15
00381932700016CardioChek® Plus Professional Analyzer270027002016-07-15
00381932701013CardioChek® Plus Professional Analyzer270127012016-07-15
00381932702010CardioChek® Plus Professional Analyzer, Refurbished270227022016-07-15
00021292015022TRUE+ A1CNow Self Check307530752023-07-30
00381932488013Assy Vial, eGLU, 13 ct.REF 2488REF 24882023-07-30
10021292015029TRUE+ A1CNow Self CheckC8H01-02C8H01-022023-07-30
00381932400015PTS Panels Metabolic ChemistryTest Strips (15-ct)240024002016-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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