FDA.reportPublic FDA data

Hydrashift 2 4 isatuximab

Primary DI
03607360046425
Brand
Hydrashift 2 4 isatuximab
Company
SEBIA
Model
4642
Catalog number
4642
Published
2022-12-08
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
CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203184000HYDRASHIFT 2/4 isatuximabSebia2021-11-12CFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607360046425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607360046425036073600464253607360046425

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry protein IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen.

Storage And Handling#

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

Regulatory Flags#

DUNS number
276801933
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
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
03607360012444CAPILLARYS 3 DBS124412442024-04-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03607360043165ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 & 9 IF MAXI-KIT (DYNAMIC MASK)SEBIACFF2026-01-09
03607360043875HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)SEBIACFF2026-01-09
03607360048160ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 IF MAXI-KIT (STANDARD MASK)SEBIACFF2026-01-09
03607360048177ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 IF MAXI-KIT (STANDARD MASK)SEBIACFF2026-01-09
03607360048191ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT(STANDARD MASK)SEBIACFF2026-01-09
03607360043196ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT (DYNAMIC MASK)SEBIACFF2026-01-08
03607360043868HYDRAGEL 4 IF MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)SEBIACFF2026-01-08
03607360043899HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)SEBIACFF2026-01-08
03607360048863HYDRAGEL 4 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)SEBIACFF2026-01-08
03607360048870HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)SEBIACFF2026-01-08
03607360048894HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)SEBIACFF2026-01-08
M5255527370SPIFE Nexus IFE-6 Antisera KitHELENA LABORATORIES CORPORATIONCFF2024-09-27
M5255527440SPIFE Nexus IFE-9/15 Antisera KitHELENA LABORATORIES CORPORATIONCFF2024-09-27
03607360026014ANTISERA CAPI 3 IT (10)SEBIACFF2023-11-29
03607360026021Sample Diluent CAPI 3 IT (10)SEBIACFF2023-11-29
M5255526940SPIFE Nexus IFE-6 Gel KitHELENA LABORATORIES CORPORATIONCFF2022-05-26
M5255526950SPIFE Nexus IFE-9 Gel KitHELENA LABORATORIES CORPORATIONCFF2022-05-26
M5255526970SPIFE Nexus Antisera 9/15 KitHELENA LABORATORIES CORPORATIONCFF2022-05-25
M5255527030SPIFE Nexus IFE-6 Antisera KitHELENA LABORATORIES CORPORATIONCFF2022-05-25
03607360046395HYDRASHIFT 2 4 daratumumab 20 testsSEBIACFF2019-07-01
M52518010000V8 E-Class Velocity CE Analyzer (220V)HELENA LABORATORIES CORPORATIONCFF2018-06-19
M52518200V8 WASTE DRAWER PACKHELENA LABORATORIES CORPORATIONCFF2018-06-19
M52518250000V8 Nexus CE Analyzer (115V/230V)HELENA LABORATORIES CORPORATIONCFF2018-06-19
03607360021002CAPILLARYS IMMUNOTYPINGSEBIACFF2018-01-24
03607360023006IT/IF ControlSEBIACFF2018-01-24
03607360026007CAPI 3 IMMUNOTYPINGSEBIACFF2018-01-24
M52518210V8 Gel IFE Diluent Barcode LabelsHELENA LABORATORIES CORPORATIONCFF2016-09-30
M52518000000V8 Velocity CE Analyzer (110V) Not Inpeco ReadyHELENA LABORATORIES CORPORATIONCFF2016-09-30
M52518000010V8 Velocity CE Analyzer (110V) Inpeco ReadyHELENA LABORATORIES CORPORATIONCFF2016-09-30
M52518030V8 Immunodisplacement KitHELENA LABORATORIES CORPORATIONCFF2016-09-24