FDA.reportPublic FDA data

Amido Black Protein Stain (powder)

Primary DI
M52530480
Brand
Amido Black Protein Stain (powder)
Company
HELENA LABORATORIES CORPORATION
Model
3048
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
M52530480PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Protein electrophoresis 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 determining the qualitative and/or quantitative separation of proteins by electrophoresis, in a clinical specimen.

Contacts#

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

Regulatory Flags#

DUNS number
079396131
Device count
1
Lot or batch
true
Expiration date on label
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