CAPILLARYS 3 DBS

Primary DI
03607360012444
Brand
CAPILLARYS 3 DBS
Company
SEBIA
Model
1244
Catalog number
1244
Device description
INSTRUMENT
Published
2024-04-30
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
GKAAbnormal Hemoglobin Quantitation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKAAbnormal Hemoglobin QuantitationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232027000CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentSebia2024-04-04GKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607360012444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607360012444036073600124443607360012444

GMDN Terms#

Term, Definition table
TermDefinition
Electrophoresis analyser IVDAn electrically-powered automated or semi-automated laboratory instrument or system intended to be used for the qualitative and/or quantitative in vitro determination of various molecules (e.g., DNA, RNA, proteins) in a clinical specimen based on their size, ionic charge and/or rate of migration through an electrically charged field.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid contact with water_Dangerous Voltage_Do not store near magnets or magnetic devices_Fragile handle with care_Keep away from sunlight_This way up
Storage Environment Humidity5 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276801933
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03607360043165ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 & 9 IF MAXI-KIT (DYNAMIC MASK)431643162026-01-09
03607360043189ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONES MAXI-KIT(DYNAMIC MASK)431843182026-01-09
03607360043875HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)438743872026-01-09
03607360048160ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 IF MAXI-KIT (STANDARD MASK)481648162026-01-09
03607360048177ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 IF MAXI-KIT (STANDARD MASK)481748172026-01-09
03607360048184ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONESMAXI-KIT(STANDARD MASK)481848182026-01-09
03607360048191ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT(STANDARD MASK)481948192026-01-09
03607360043196ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT (DYNAMIC MASK)431943192026-01-08
03607360043868HYDRAGEL 4 IF MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)438643862026-01-08
03607360043882HYDRAGEL 9 BENCE JONES MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)438843882026-01-08
03607360043899HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)438943892026-01-08
03607360048863HYDRAGEL 4 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)488648862026-01-08
03607360048870HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)488748872026-01-08
03607360048887HYDRAGEL 9 BENCE JONES MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)488848882026-01-08
03607360048894HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)488948892026-01-08
03607360025062CAPI 3 NEONAT Hb250625062024-04-30
03607360025635CAPI 3 NEONAT HEMOLYSING SOLUTION256325632024-04-30
03607360025789CAPILLARYS 3 DBS MICROPLATES257825782024-04-30
03607360047576CAPI 3 NEONAT Hb AF Control475747572024-04-30
03607360047927Hb AFSC Control479247922024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05391516744102Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
05391516744119Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
05391516748179Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
05391516748186Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
00847817007354VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008276VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008283VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008306VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008313VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
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
05391516744195Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06
05391516744201Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06
05391516744232Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06
05391516744249Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06