Hemochron Whole Blood Coagulation System

Primary DI
10711234102183
Brand
Hemochron Whole Blood Coagulation System
Company
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Model
RQCPRT
Catalog number
RQCPRT
Device description
RxDx Whole Blood Quality Control Protamine 40/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
GFTProtamine Sulphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFTProtamine SulphateHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910105000PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200International Technidyne Corp.1991-02-26GFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10711234102183PrimaryGS10
00711234102186Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1071123410218310711234102183
00711234102186007112341021867112341021860711234102186

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature35 Degrees Fahrenheit46 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
40
DM 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
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
10711234170243directCHECK Whole Blood ControlsDCJLR-NDCJLR-N2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10711234202050Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.GFT2016-09-22
10711234202067Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.GFT2016-09-22