Thrombin Clotting Time Reagent

Primary DI
M52553770
Brand
Thrombin Clotting Time Reagent
Company
HELENA LABORATORIES CORPORATION
Model
5377
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
GJATEST, THROMBIN TIME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJATest, Thrombin TimeHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K920147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K920147000THROMBIN CLOTTING TIME REAGENTHelena Laboratories1992-05-01GJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52553770PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thrombin time (TT) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of the thrombin time (TT) of a clinical specimen using a clotting method.

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

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414639635Test Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHGJA2024-03-25
10859394006054T-tekR 2 DIAGNOSTICS, INC.GJA2016-11-15
00842768012716Test Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHGJA2016-09-24
00842768013102BC Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHGJA2016-09-24
08426950058366HemosIL Thrombin TimeINSTRUMENTATION LABORATORY COMPANYGJA2016-09-23
13607450006114STA® - Thrombin 2DIAGNOSTICA STAGOGJA2016-09-15
13607450006695STA® - Thrombin 10DIAGNOSTICA STAGOGJA2016-09-15