FDA.reportPublic FDA data

CAPICLEAN

Primary DI
03607360020586
Brand
CAPICLEAN
Company
SEBIA
Model
2058
Catalog number
2058
Device description
CAPICLEAN IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K082085
Published
2022-12-16
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
03607360020586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607360020586036073600205863607360020586

GMDN Terms#

Term, Definition table
TermDefinition
Wash/cleaning solution IVD, automated/semi-automated systemA concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00DO NOT FREEZE FRAGILE HANDLE WITH CARE PROTECT FROM HEAT THIS WAY UP
Storage Environment Temperature2 Degrees Celsius8 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
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
03607360041055HYDRAGEL 7 HR AMIDO BLACK SEBIACEF2022-12-08