FDA.reportPublic FDA data

TITAN GEL IFE Antiserum Trivalent (G, A, M)

Primary DI
M52594110
Brand
TITAN GEL IFE Antiserum Trivalent (G, A, M)
Company
HELENA LABORATORIES CORPORATION
Model
9411
Published
2016-09-07
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
CFQRADIOIMMUNOASSAY, IMMUNOGLOBULINS (G, A, M)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFQRadioimmunoassay, Immunoglobulins (G, A, M)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K891188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K891188000TITAN GEL IFE TRIVALENT ANTISERUMHelena Laboratories1989-03-22CFQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52594110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polyvalent human immunoglobulin antibody 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 the qualitative and/or quantitative detection of all classes of human immunoglobulin (i.e, IgA, IgE, IgD, IgG, IgM) and/or specific immunoglobulin chains 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
05051700010450Human IgA - ‘NL’ BINDARID™ Radial Immunodiffusion Kit THE BINDING SITE GROUP LIMITEDCFQ2016-09-24
05051700010467Human IgM - ‘NL’ BINDARID™ Radial Immunodiffusion Kit THE BINDING SITE GROUP LIMITEDCFQ2016-09-24
00842768005688Dimension® Flex® reagent cartridge IGASiemens Healthcare Diagnostics Inc.CFQ2016-09-24
00842768005701Dimension® Flex® reagent cartridge IGGSiemens Healthcare Diagnostics Inc.CFQ2016-09-24
00842768005732Dimension® Flex® reagent cartridge IGMSiemens Healthcare Diagnostics Inc.CFQ2016-09-24