FDA.reportPublic FDA data

Epinephrine Reagent

Primary DI
M52553670
Brand
Epinephrine Reagent
Company
HELENA LABORATORIES CORPORATION
Model
5367
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
GHRREAGENT, PLATELET AGGREGATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHRReagent, Platelet AggregationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910680000EPINEPHRINE REAGENT, CAT. NO. 5367Helena Laboratories1991-05-20GHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52553670PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Platelet aggregation study 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 evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, which may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.

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
00811476010048CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
00811476010055CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
00811476010062CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
00811476010086CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
00811476010147CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
15391521420067Adenosine Diphosphate (ADP)TCOAG IRELAND LIMITEDGHR2016-09-12
15391521420081Ristocetin (7.5 mg/vial)TCOAG IRELAND LIMITEDGHR2016-09-12
M52553660ADP ReagentHELENA LABORATORIES CORPORATIONGHR2016-09-07
M52553680Collagen ReagentHELENA LABORATORIES CORPORATIONGHR2016-09-07
M52553690Platelet Aggregation KitHELENA LABORATORIES CORPORATIONGHR2016-09-07
M52558640Plateletworks Arachidonic Acid KitHELENA LABORATORIES CORPORATIONGHR2016-09-07