FDA.reportPublic FDA data

Perfect 3

Primary DI
04719871820285
Brand
Perfect 3
Company
BIOTEST MEDICAL CORPORATION
Model
GOD31
Device description
Perfect 3 Control Solution-High
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
04719871820285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871820285047198718202854719871820285

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.

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
04719871820261Perfect 388182017-02-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750035847VITROSORTHO CLINICAL DIAGNOSTICSJJX2026-07-21
00850078377265iHealthiHealth Labs Inc.NBW2026-07-14
00860015091604KetoBMKETOBM USA LLCNBW2026-07-14
00860015091611KetoBMKETOBM USA LLCNBW2026-07-14
00860015091628KetoBMKETOBM USA LLCNBW2026-07-14
00860015091635KetoBMKETOBM USA LLCNBW2026-07-14
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706973medisana BG 150 Blood Glucose Monitoring SystemTYSON BIORESEARCH INC.NBW2026-07-13
04719869706980medisana BG 150 Blood Glucose Test Strips (50Tx2)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706997medisana BG 150 Control Solution (Level 2)TYSON BIORESEARCH INC.NBW2026-07-13
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