FDA.reportPublic FDA data

GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)

Primary DI
10711234103401
Brand
GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)
Company
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Model
000GACT+
Catalog number
000GACT+
Device description
GH100 ACT+ 45 cuvettes/box.
Published
2022-01-21
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202101000GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2Accriva Diagnostics, Inc.2021-12-29JPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10711234103401PrimaryGS10
00711234103404Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1071123410340110711234103401
00711234103404007112341034047112341034040711234103404

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 Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature35 Degrees Fahrenheit46 Degrees Fahrenheit

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
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
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
B55880004121Sonoclot® gbACT+ KitSIENCO, INC.JBP2021-05-26