FDA.reportPublic FDA data

CRYOcheck Hex LA

Primary DI
00843876000527
Brand
CRYOcheck Hex LA
Company
Precision Biologic Inc
Model
Hex LA-7
Catalog number
HEXLA-7
Device description
CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.
Published
2020-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K193556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193556000Cryocheck Hex LAPrecision Biologic2020-10-23GFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843876000527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843876000527008438760005278438760005270843876000527

GMDN Terms#

Term, Definition table
TermDefinition
Lupus anticoagulant marker IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen, using a clotting method.

Regulatory Flags#

DUNS number
244713368
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843876000015CRYOcheck™ Pooled Normal PlasmaCCN-102016-09-23
00843876000022CRYOcheck™ Pooled Normal PlasmaCCN-152016-09-23
00843876000039CRYOcheck™ Pooled Normal PlasmaCCN10-102016-09-23
00843876000046CRYOcheck™ Pooled Normal PlasmaCCN-402016-09-23
00843876000053CRYOcheck™ Reference Control NormalRCN-052016-09-23
00843876000060CRYOcheck™ Reference Control NormalRCN-102016-09-23
00843876000077CRYOcheck™ Abnormal 1 Reference ControlARP1-052016-09-23
00843876000084CRYOcheck™ Abnormal 1 Reference ControlARP1-102016-09-23
00843876000091CRYOcheck™ Abnormal 2 Reference ControlARP2-102016-09-23
00843876000190CRYOcheck™ Normal Reference PlasmaCCNRP-052016-09-23
00843876000206CRYOcheck™ Normal Reference PlasmaCCNRP-102016-09-23
00843876000213CRYOcheck™ Factor II Deficient PlasmaFDP02-102016-09-23
00843876000220CRYOcheck™ Factor II Deficient PlasmaFDP02-152016-09-23
00843876000237CRYOcheck™ Factor V Deficient PlasmaFDP05-102016-09-23
00843876000244CRYOcheck™ Factor V Deficient PlasmaFDP05-152016-09-23
00843876000251CRYOcheck™ Factor VII Deficient PlasmaFDP07-102016-09-23
00843876000268CRYOcheck™ Factor VII Deficient PlasmaFDP07-152016-09-23
00843876000275CRYOcheck™ Factor VIII Deficient PlasmaFDP08-102016-09-23
00843876000282CRYOcheck™ Factor VIII Deficient PlasmaFDP08-152016-09-23
00843876000299CRYOcheck™ Factor VIII Deficient PlasmaFDP08-402016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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
10711234103029Hemochron Whole Blood Microcoagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.GFO2016-09-22
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