FDA.reportPublic FDA data

ExtendSure

Primary DI
09421902348112
Brand
ExtendSure
Company
CANTERBURY SCIENTIFIC LIMITED
Model
107253
Catalog number
HB510Ar
Device description
The lypholised Hemoglobin A1c Linearity controls are prepared from human blood and contain normal hemoglobin, preservatives and stabilizers. The controls are formulated to give enhanced stability.The Lyophilized Hemoglobin A1c Linearity Controls are intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols setup within individual clinical laboratories.
Published
2020-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421902348112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421902348112094219023481129421902348112

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
590649471
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421902348006ExtendSUREB123962018-09-20
09421902348020ExtendSUREHB6102018-09-20
09421902348037ExtendSUREHB110SSBAr2018-09-20
09421902348044ExtendSUREHB110SCALAr2018-09-20
09421902348051Tosoh US9970502018-11-02
09421902348068TOSOH2202322016-10-24
09421902348075ExtendSUREHB710SBAr2018-09-20
09421902348082ExtendSUREHB5102018-09-20
09421902348099ExtendSUREB123972018-09-20
09421902348105Tosoh EU9970502018-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00195126001045NOVA Lite® IFA Yo (PCA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00850011135877VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-05
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
10758750035380VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-05-20
10758750035076VITROSORTHO CLINICAL DIAGNOSTICSJJX2024-09-18
00021292015091TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSJJX2022-08-09
00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
14987481164441uTASWako AFP-L3 Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164458uTASWako AFP-L3 Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23