FDA.reportPublic FDA data

HYDRAGEL 9 BENCE JONES MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)

Primary DI
03607360048887
Brand
HYDRAGEL 9 BENCE JONES MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)
Company
SEBIA
Model
4888
Catalog number
4888
Published
2026-01-08
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
JKMImmunochemical, Bence-Jones Protein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKMImmunochemical, Bence-Jones ProteinImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607360048887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607360048887036073600488873607360048887

GMDN Terms#

Term, Definition table
TermDefinition
Protein electrophoresis IVD, kit, electrophoresisA collection of reagents and other associated materials intended to be used for determining the qualitative and/or quantitative separation of proteins in a clinical specimen, using an electrophoresis method.

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, Specify00Do Not Freeze
Special Storage Condition, Specify00Fragile-Handle with Care
Special Storage Condition, Specify00This Way Up
Storage Environment Temperature2 Degrees Celsius30 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
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
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
03607360043189ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONES MAXI-KIT(DYNAMIC MASK)SEBIAJKM2026-01-09
03607360048184ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONESMAXI-KIT(STANDARD MASK)SEBIAJKM2026-01-09
03607360043882HYDRAGEL 9 BENCE JONES MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)SEBIAJKM2026-01-08