FDA.reportPublic FDA data

ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT(STANDARD MASK)

Primary DI
03607360048191
Brand
ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT(STANDARD MASK)
Company
SEBIA
Model
4819
Catalog number
4819
Device description
ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT (STANDARD MASK)
Published
2026-01-09
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607360048191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607360048191036073600481913607360048191

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
Special Storage Condition, Specify00AVOID CONTACT WITH WATER
Special Storage Condition, Specify00Consult Instructions for Use, Logo GHS07
Special Storage Condition, Specify00FRAGLE HANDLE WITH CARE
Special Storage Condition, Specify00THIS WAY UP
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276801933
Device count
1
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
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
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
03607360047927Hb AFSC Control479247922024-04-30

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
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
03607360046425Hydrashift 2 4 isatuximabSEBIACFF2022-12-08
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