FDA.reportPublic FDA data

RESOLVE Systems Hemoglobin Kit

Primary DI
06438147000784
Brand
RESOLVE Systems Hemoglobin Kit
Company
Wallac Oy
Model
FR-9120
Catalog number
FR-9120
Device description
For detection of normal and variant hemoglobins.
Published
2016-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GKAAbnormal Hemoglobin Quantitation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKAAbnormal Hemoglobin QuantitationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050709000RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367Wallac OY2006-03-08GKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147000784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147000784064381470007846438147000784

GMDN Terms#

Term, Definition table
TermDefinition
Multiple haemoglogbin subtype IVD, kit, electrophoresisA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or 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
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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06438147344406AutoDELFIA Inhibin A kit Level Calibrators B064-112-P2B064-112-P22018-11-21
06438147344420AutoDELFIA Inhibin A kit B064-112B064-1122017-10-10
06438147355037AutoDELFIA Unconjugated Estriol (uE3) kitB095-112B095-1122018-11-16
06438147377732Eonis SCID-SMA kit3241-001U3241-001U2022-11-30
06438147377756Eonis SCID-SMA kit3242-001U3242-001U2022-11-30
06438147121373VICTOR2 D1420-0211420-0212019-03-19
06438147333202VICTOR EnLite1420-02201420-02202019-03-19
06438147333219VICTOR EnLite1420-02301420-02302019-03-19
06438147064540Wallac Plate Shake1296-0041296-0042019-02-25
06438147009176DELFIA hCG kitA007-101A007-1012016-02-11
06438147009343AutoDELFIA hCG kitB007-112B007-1122016-02-11
06438147391998DBS Controls LysoPC3413-00103413-00102024-01-08
06438147392339LysoPC IS4417-00104417-00102024-01-08
06438147009336AutoDELFIA hCG kit B007-101B007-1012016-02-11
06438147356218NeoLSD MSMS kit3093-001U3093-001U2018-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03607360012444CAPILLARYS 3 DBSSEBIAGKA2024-04-30
03607360025062CAPI 3 NEONAT HbSEBIAGKA2024-04-30
03607360025635CAPI 3 NEONAT HEMOLYSING SOLUTIONSEBIAGKA2024-04-30
03607360025789CAPILLARYS 3 DBS MICROPLATESSEBIAGKA2024-04-30
00847817000560VARIANT nbs Newborn ScreeningBIO-RAD LABORATORIES, INC.GKA2023-01-31
00847817007057Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007064Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007071Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007156Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007170Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007187Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
03607360020074CAPILLARYS HEMOGLOBINSEBIAGKA2018-01-24
03607360022078MINICAP HEMOGLOBINSEBIAGKA2018-01-24
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05391516748179Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
05391516748186Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
00847817007354VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
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00847817008306VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
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00847817008344VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008351VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
M52551250Hemolysate ReagentHELENA LABORATORIES CORPORATIONGKA2016-09-07
M52551270Hemolysate ReagentHELENA LABORATORIES CORPORATIONGKA2016-09-07
M52551280Hemolysate ReagentHELENA LABORATORIES CORPORATIONGKA2016-09-07
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