FDA.reportPublic FDA data

CRYOcheck Hex LA

Primary DI
00843876000510
Brand
CRYOcheck Hex LA
Company
Precision Biologic Inc
Model
Hex LA
Catalog number
Hex LA
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
00843876000510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843876000510008438760005108438760005100843876000510

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

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Primary DI, Brand, Company table
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00630414640716Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
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00842768019074Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00850053916199IDG/SanzayIDG/SANZAY CorporationGFO2024-01-12
00843876000596CRYOcheck Hex LAPrecision Biologic IncGFO2023-05-02
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00817869020014Slide Platelet Aggregation Test ReagentANALYTICAL CONTROL SYSTEMS INCGFO2019-01-31
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00842768003851Dade® Actin® Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
00842768007521Pathromtin® SLSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
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