FDA.reportPublic FDA data

Hemochron Whole Blood Microcoagulation System

Primary DI
10711234103029
Brand
Hemochron Whole Blood Microcoagulation System
Company
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Model
J103C
Catalog number
J103C
Device description
Citrate APTT Cuvette - 45 test cuvettes/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
GFOActivated Partial Thromboplastin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFOActivated Partial ThromboplastinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972831000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972831000HEMOCHRON CITRATE APTTInternational Technidyne Corp.1997-11-20GFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10711234103029PrimaryGS10
00711234103022Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1071123410302910711234103029
00711234103022007112341030227112341030220711234103022

GMDN Terms#

Term, Definition table
TermDefinition
Activated partial thromboplastin time (APTT) 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 partial thromboplastin time (APTT) of 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
45
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
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
00630414640310Dade Actin Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00630414640334Dade Actin Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00630414640709Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00630414640716Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00842768019579Dade Actin Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00842768019074Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00850053916199IDG/SanzayIDG/SANZAY CorporationGFO2024-01-12
00843876000596CRYOcheck Hex LAPrecision Biologic IncGFO2023-05-02
00843876000510CRYOcheck Hex LA Precision Biologic IncGFO2020-11-05
00843876000527CRYOcheck Hex LAPrecision Biologic IncGFO2020-11-05
00817869020014Slide Platelet Aggregation Test ReagentANALYTICAL CONTROL SYSTEMS INCGFO2019-01-31
00842768003837Dade® Actin® Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
00842768003851Dade® Actin® Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
00842768007521Pathromtin® SLSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
00842768007538Pathromtin® SLSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
08426950087649HemosIL SynthAFaxINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950433491HemosIL Silica Clotting TimeINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950023487HemosIL Calcium Chloride 0.025M (for APTT-SP kit)INSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950078920HemosIL SynthASilINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950078937HemosIL APTT-SPINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950915676GEM TEST APTT CITRATEINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950087632HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax)INSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
00627944000097QuikCoag Calcium Chloride 0.02MBiomedica Diagnostics IncGFO2016-09-22
00627944000103QuikCoag Calcium Choride 0.02MBiomedica Diagnostics IncGFO2016-09-22
00627944000042QuikCoag APTT-EABiomedica Diagnostics IncGFO2016-09-22
00627944000059QuikCoag APTT-EABiomedica Diagnostics IncGFO2016-09-22
10627944000094QuikCoag Calcium Chloride 0.02MBiomedica Diagnostics IncGFO2016-09-22
10627944000100QuikCoag Calcium Choride 0.02MBiomedica Diagnostics IncGFO2016-09-22
00845275000511Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGFO2016-09-16
00845275000641Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGFO2016-09-16