FDA.reportPublic FDA data

ExtendSURE

Primary DI
09421902348044
Brand
ExtendSURE
Company
CANTERBURY SCIENTIFIC LIMITED
Model
HB110SCALAr
Device description
The lyophilised Hemoglobin F and A2 with HbS in level 2 Calibrator kit contains 2 vials each of level 1 and level 2 calibrator which are prepared as a stabilized hemolysate from human blood. The calibrators are designed to establish known points of reference in laboratory testing procedures.
Published
2018-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JCMControl, Hemoglobin, Abnormal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCMControl, Hemoglobin, AbnormalHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421902348044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421902348044094219023480449421902348044

GMDN Terms#

Term, Definition table
TermDefinition
Multiple haemoglobin subtype 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 determination of one or multiple subtypes of haemoglobin 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
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
09421902348112ExtendSure107253HB510Ar2020-10-12
09421902348006ExtendSUREB123962018-09-20
09421902348020ExtendSUREHB6102018-09-20
09421902348037ExtendSUREHB110SSBAr2018-09-20
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
03607360047576CAPI 3 NEONAT Hb AF ControlSEBIAJCM2024-04-30
03607360047927Hb AFSC ControlSEBIAJCM2024-04-30
03607360047583Hb AFSA2 CONTROL (1)SEBIAJCM2023-07-27
03607360047590Hb AFSA2 CONTROL (5)SEBIAJCM2023-07-27
06438147385478RESOLVE Hb FACS Control kitWallac OyJCM2023-04-17
B115ABCARD11371Advin Multi-Drug Screen Test ADVIN BIOTECH, INC.JCM2021-12-17
09421902348051Tosoh USCANTERBURY SCIENTIFIC LIMITEDJCM2018-11-02
09421902348105Tosoh EUCANTERBURY SCIENTIFIC LIMITEDJCM2018-11-02
09421902348020ExtendSURECANTERBURY SCIENTIFIC LIMITEDJCM2018-09-20
09421902348037ExtendSURECANTERBURY SCIENTIFIC LIMITEDJCM2018-09-20
00847661000884LyphochekBIO-RAD LABORATORIES, INC.JCM2016-09-12
00847661002093LyphochekBIO-RAD LABORATORIES, INC.JCM2016-09-12
M52553330Abnormal HbA2 Quik Column ControlHELENA LABORATORIES CORPORATIONJCM2016-09-07
M52553390Normal HbA2 Quik Column ControlHELENA LABORATORIES CORPORATIONJCM2016-09-07
05391516744393Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06
05391516744409Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06
05391516748315Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06
05391516748322Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06