FDA.reportPublic FDA data

RESOLVE Hb FACS Control kit

Primary DI
06438147385478
Brand
RESOLVE Hb FACS Control kit
Company
Wallac Oy
Model
3412-0010
Catalog number
3412-0010
Device description
A control for monitoring assay performance in isoelectric focusing techniques used for identifying hemoglobin variants.
Published
2023-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
06438147385478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147385478064381473854786438147385478

GMDN Terms#

Term, Definition table
TermDefinition
Multiple haemoglobin subtype IVD, kit, electrophoresisA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of multiple subtypes of haemoglobin in a clinical specimen, using an electrophoresis method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540156544
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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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
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
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09421902348044ExtendSURECANTERBURY 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
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05391516744409Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06
05391516748315Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06
05391516748322Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06