FDA.reportPublic FDA data

Perfect 3

Primary DI
04719871820261
Brand
Perfect 3
Company
BIOTEST MEDICAL CORPORATION
Model
8818
Device description
Perfect 3 Blood Glucose Test Strip1.Part Number:BY8818G0NL42.Packing Materials No.:BL8818PEA
Published
2017-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719871820261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871820261047198718202614719871820261

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658447255
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719871820070Easy Plus II8818(BY8818G0NL4)2016-05-02
04719871820100Easy Plus II 8818(BZ8818G0HAB)2016-05-02
04719871820155Easy Talk8818(BZ8818G0HAA)2016-05-02
04719871820162Easy Talk8818(BY8818G0NL4)2016-05-02
04719871820230Oracle8818/BL8818ROA2016-11-29
04719871820339NuvoMed58192018-03-07
04719871820315NuvoMed P5228 BGM-6/0352 2018-03-07
04719871820322NuvoMed P5228 BGM-6/0352 2018-03-07
04719871820001Smartest PersonaII6276-S2016-03-02
04719871820018Smartest PersonaII 88192016-03-02
04719871820025Smartest PersonaIIGOD212016-03-02
04719871820032Smartest PersonaII 6276-S2016-03-02
04719871820049B T M82282016-03-02
04719871820056Easy Plus II6276-S(BZG60276HA)2016-05-02
04719871820063Easy Plus II6276-S(BYG60276HA)2016-05-02
04719871820087Easy Plus IIGOD11(BYGOD31BT)2016-05-02
04719871820094Easy Plus IIGOD31(BZL001HAB)2016-05-02
04719871820117Easy Plus IIGOD31(BZH002HAB)2016-05-02
04719871820124Easy Plus IIGOD11(BZL002HAB)2016-05-02
04719871820131Easy Talk6277(BZG62277HAA)2016-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08718734960584Eurotrol GlucoTrol-NG Eurotrol B.V.JJX2020-10-08
08718734960607Eurotrol GlucoTrol-NG Eurotrol B.V.JJX2020-10-08
08718734960621Eurotrol AlbuTrolEurotrol B.V.JJX2020-10-08
08718734960645Eurotrol AlbuTrolEurotrol B.V.JJX2020-10-08
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
08809301160862Pip Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2020-09-11
10054749005519i-STATABBOTT POINT OF CARE INC.CGA2020-05-01
10096295139553TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-04-10
10021292014299TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-03-18
10021292014305TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-03-18
10021292014312TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-03-18
10021292014329TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-03-18