FDA.reportPublic FDA data

Hemochron Whole Blood Coagulation System

Primary DI
10711234101094
Brand
Hemochron Whole Blood Coagulation System
Company
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Model
P214
Catalog number
P214
Device description
ACT Tubes 95 tubes/box
Published
2016-09-22
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
JBPActivated Whole Blood Clotting Time

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBPActivated Whole Blood Clotting TimeHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10711234101094PrimaryGS10
00711234101097Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1071123410109410711234101094
00711234101097007112341010977112341010970711234101097

GMDN Terms#

Term, Definition table
TermDefinition
Activated clotting time (ACT) 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 quantitative measurement of the activated clotting time (ACT) of a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-678-0710ilsd_ra.na@werfen.com

Regulatory Flags#

DUNS number
079299318
Device count
95
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10711234170342directCHECK ACT+ Whole Blood Control Level 1000DCGACT-1000DCGACT-12022-01-21
10711234170359directCHECK ACT+ Whole Blood Control, Level 2000DCGACT-2000DCGACT-22022-01-21
10711234170366directCHECK ACT-LR Whole Blood Controls, Level 1000DCGLR-1000DCGLR-12022-01-21
10711234170373directCHECK ACT-LR Whole Blood Control, Level 2000DCGLR-2000DCGLR-22022-01-21
10711234101230Hemochron Whole Blood Coagulation SystemPDAOPDAO2016-09-22
10711234102176Hemochron Whole Blood Coagulation SystemRQCHRTRQCHRT2016-09-22
10711234102183Hemochron Whole Blood Coagulation SystemRQCPRTRQCPRT2016-09-22
10711234102206Hemochron Whole Blood Coagulation SystemQCACTQCACT2016-09-22
10711234107027directCHECK Whole Blood ControlsDCJAPTT-NDCJAPTT-N2016-09-22
10711234107034directCHECK Whole Blood ControlsDCJAPTT-ADCJAPTT-A2016-09-22
10711234107041directCHECK Whole Blood ControlsDCJPT-ADCJPT-A2016-09-22
10711234107058directCHECK Whole Blood ControlsDCJACT-ADCJACT-A2016-09-22
10711234107065directCHECK Whole Blood ControlsDCJCPT-ADCJCPT-A2016-09-22
10711234107072directCHECK Whole Blood ControlsDCJCPT-NDCJCPT-N2016-09-22
10711234107089directCHECK Whole Blood ControlsDCJLR-ADCJLR-A2016-09-22
10711234107096HepCheck Whole Blood ControlDCP214-NDCP214-N2016-09-22
10711234107102HepCheck Whole Blood ControlDCP214-ADCP214-A2016-09-22
10711234170175directCHECK Whole Blood ControlsDCJCAPTT-ADCJCAPTT-A2016-09-22
10711234170229directCHECK Whole Blood ControlsDCJACT-NDCJACT-N2016-09-22
10711234170236directCHECK Whole Blood ControlsDCJPT-NDCJPT-N2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000558338HR HTCMEDTRONIC, INC.JBP2026-02-23
20763000558332HR HTCMEDTRONIC, INC.JBP2026-02-23
00763000558192CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558208CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558215CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558222CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558239CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558196CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558202CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558219CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558226CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558233CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
B558DP29510Sonoclot® Coagulation & Platelet Function AnalyzerSIENCO, INC.JBP2023-06-28
20763000433813LR-ACTMEDTRONIC, INC.JBP2023-04-08
20763000433844HR-ACTMEDTRONIC, INC.JBP2023-04-08
00763000433819LR-ACTMEDTRONIC, INC.JBP2023-04-08
00763000433840HR-ACTMEDTRONIC, INC.JBP2023-04-08
20763000441450NAMEDTRONIC, INC.JBP2023-04-07
00763000441456NAMEDTRONIC, INC.JBP2023-04-07
10711234103401GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
10711234103418GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
00711234103404GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
00711234103411GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
20643169730155N/AMEDTRONIC, INC.JBP2021-11-12
00643169730151N/AMEDTRONIC, INC.JBP2021-11-12
B55880004411Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004421Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004410Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004420Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004111Sonoclot® gbACT+ KitSIENCO, INC.JBP2021-05-26