FDA.reportPublic FDA data

Helena Ristocetin

Primary DI
M52551990
Brand
Helena Ristocetin
Company
HELENA LABORATORIES CORPORATION
Model
5199
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
JOZSYSTEM, AUTOMATED PLATELET AGGREGATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOZSystem, Automated Platelet AggregationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K800432000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K800432000HELENA RISTOCETINHelena Laboratories1980-03-25JOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52551990PrimaryHIBCC0

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
04589448510082PL ChipZACROS CORPORATIONJOZ2024-12-12
04589448510099PL Chip Reservoir SetZACROS CORPORATIONJOZ2024-12-12
04589448510105BAPA tubeZACROS CORPORATIONJOZ2024-12-12
04589448510037PL Chip for T-TAS 01ZACROS CORPORATIONJOZ2024-12-12
04589448510044PL Chip Reservoir Set for T-TAS 01ZACROS CORPORATIONJOZ2024-12-12
04589448510051BAPA tube for T-TAS 01ZACROS CORPORATIONJOZ2024-12-12
14589448510089PL ChipZACROS CORPORATIONJOZ2024-12-12
14589448510096PL Chip Reservoir SetZACROS CORPORATIONJOZ2024-12-12
14589448510102BAPA tubeZACROS CORPORATIONJOZ2024-12-12
04589448510013T-TAS 01 Total Thrombus Formation Analysis SystemZACROS CORPORATIONJOZ2024-12-06
G0561076501AGG/PAK 5 Combo KitBio/Data CorporationJOZ2024-10-01
00811476011045CHRONO-LOGCHRONO-LOG CORPJOZ2023-06-21
00811476011670CHRONO-LOGCHRONO-LOG CORPJOZ2023-06-21
G0561009700AggRecetin Bio/Data CorporationJOZ2022-03-23
G0561012410AggRecetin Bio/Data CorporationJOZ2022-03-23
G0561012971Arachidonic AcidBio/Data CorporationJOZ2022-03-23
G0561013101PAR/PAK IIBio/Data CorporationJOZ2022-03-23
G0561013111EpinephrineBio/Data CorporationJOZ2022-03-23
G0561013121ADPBio/Data CorporationJOZ2022-03-23
G0561015621CollagenBio/Data CorporationJOZ2022-03-23
G0561015801BETA/PakBio/Data CorporationJOZ2022-03-23
10711234500095VerifyNow SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.JOZ2021-04-06
00856893004027AggreguideAGGREDYNE, INC.JOZ2019-09-23
00856893004010AggreDYNE AA AssayAGGREDYNE, INC.JOZ2019-01-01
00856893004065AggreguideAGGREDYNE, INC.JOZ2019-01-01
20856893004014AggreDYNE AA AssayAGGREDYNE, INC.JOZ2019-01-01
00856893004041AggreguideAGGREDYNE, INC.JOZ2019-01-01
10812747018302TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATIONJOZ2017-08-18
30812747018351TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATIONJOZ2017-07-31
10812747018296TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATIONJOZ2017-07-17