FDA.reportPublic FDA data

QUICKGEL MODIFIED APPLICATOR BLADES AND DEEP WELL CUPS

Primary DI
M5255521360
Brand
QUICKGEL MODIFIED APPLICATOR BLADES AND DEEP WELL CUPS
Company
HELENA LABORATORIES CORPORATION
Model
552136
Published
2017-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEFELECTROPHORETIC, PROTEIN FRACTIONATION

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972274000SPIFEHelena Laboratories1997-10-27CEF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M5255521360PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)231-5663helena@helena.com

Regulatory Flags#

DUNS number
079396131
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M52551830AB-Trol 3 Coagulation Control51832016-08-18
M52551850Coagulation S.A.R.P (Specialty Assayed Reference Plasma)51852016-09-07
M52551860NORM-TROL 1 Coagulation Control51862016-09-07
M52551870AB-TROL 2 Coagulation Control51872016-09-07
M52553010Coagulation S.A.C.-1 (Specialty Assay Control)53012016-09-07
M52553020Coagulation S.A.C.-2 (Specialty Assay Control)53022016-09-07
M52536110H-Pette without Blade (1000 pieces)36112017-05-26
M52536120H-Pette with Blade (1000 pieces)36122017-05-26
M52536130H-Pette Remover36132017-03-17
M52536150H-Pette II (No Blade, Metal Canula) (1000 pieces)36152017-05-26
M52594230IFE Free Lambda Light Chain Antiserum94232024-09-27
M5255527370SPIFE Nexus IFE-6 Antisera Kit5527372024-09-27
M5255527440SPIFE Nexus IFE-9/15 Antisera Kit5527442024-09-27
M52594190IFE IgD Antiserum94192024-09-27
M52594200IFE IgE Antiserum94202024-09-27
M52594220IFE Free Kappa Light Chain Antiserum94222024-09-27
M52520050000ProtoFluor Z (110V)20050002017-03-17
M52520050020ProtoFluor Z (110V)20050022017-03-17
M52520060000ProtoFluor Z (220V)20060002017-03-17
M52518360V8 Urine Preparation Buffer18362023-09-08

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