FDA.reportPublic FDA data

HYDRAGEL 7 HR AMIDO BLACK

Primary DI
03607360041055
Brand
HYDRAGEL 7 HR AMIDO BLACK
Company
SEBIA
Model
4105
Catalog number
4105
Device description
PROTEIN SEPARATION/FRACTIONALIZATION
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
CEFElectrophoretic, Protein Fractionation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEFElectrophoretic, Protein FractionationClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607360041055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607360041055036073600410553607360041055

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, Specify00DO NOT FREEZE FRACIGLE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
276801933
Device count
1
Premarket exempt
true
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
M52518360V8 Urine Preparation BufferHELENA LABORATORIES CORPORATIONCEF2023-09-08
M5255526930SPIFE Nexus Split Beta SPE - 80, 100 Gel KitHELENA LABORATORIES CORPORATIONCEF2023-09-08
03607360041345HYDRAGEL 15 LIPOPROTEIN(E)SEBIACEF2022-12-28
03607360041383HYDRAGEL 30 LIPOPROTEIN(E)SEBIACEF2022-12-28
03607360020524CAPILLARYS/MINICAP WASH SOLUTION (2)SEBIACEF2022-12-16
03607360020586CAPICLEAN SEBIACEF2022-12-16
03607360020593CLEAN PROTECTSEBIACEF2022-12-16
03607360020609CAPILLARYS 3 CAPICLEANSEBIACEF2022-12-16
03607360020623CAPILLARYS 3 WASH SOLUTION (1)SEBIACEF2022-12-16
03607360022511MINICAP FLEX-PIERCING CAPICLEANSEBIACEF2022-12-16
03607360025130CAPI 3 URINESEBIACEF2022-12-16
03607360045404DESTAINING SOLUTION (10)SEBIACEF2022-12-16
03607360045534ACID VIOLET STAINING SOLUTIONSEBIACEF2022-12-16
03607360045541AMIDO BLACK STAINING SOLUTIONSEBIACEF2022-12-16
03607360045879FLUIDILSEBIACEF2022-12-16
03607360045893DTT DILUENT (IF/IT)SEBIACEF2022-12-16
03607360020432CAPILLARYS PROTEIN(E) 6 BUFFERSEBIACEF2022-12-12
03607360022436MINICAP PROTEIN(E) 6 BUFFERSEBIACEF2022-12-12
03607360030042HYDRAGEL PROTEINURIE K20SEBIACEF2022-12-12
03607360041154HYDRAGEL 5 PROTEINURIESEBIACEF2022-12-12
03607360020036CAPILLARYS PROTEINE 6SEBIACEF2022-12-08
03607360022030MINICAP PROTEINE 6SEBIACEF2022-12-08
03607360022238MINICAP PROTEINE 6 MAXI KITSEBIACEF2022-12-08
03607360025031CAPI 3 PROTEINE 6SEBIACEF2022-12-08
03607360030004HYDRAGEL PROTEINE K20SEBIACEF2022-12-08
03607360030011HYDRAGEL HR K20SEBIACEF2022-12-08
03607360032008HYDRAGEL PROTEIN K20 MAXI KITSEBIACEF2022-12-08
03607360041000HYDRAGEL 7 PROTEINESEBIACEF2022-12-08
03607360041017HYDRAGEL 7 B1-B2SEBIACEF2022-12-08
03607360041024HYDRAGEL 7 HR ACID VIOLETSEBIACEF2022-12-08