FDA.reportPublic FDA data

Lupus anticoagulant marker IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen.
GUDID devices
21
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414640013LA Control LowSiemens Healthcare Diagnostics Products GmbH108739352024-03-29
00630414640099LA Control HighSiemens Healthcare Diagnostics Products GmbH108739362024-03-29
00842768019678LA Control LowSiemens Healthcare Diagnostics Products GmbH108739352024-03-29
00842768019685LA Control HighSiemens Healthcare Diagnostics Products GmbH108739362024-03-29
08426950513728HemosIL LA Negative ControlINSTRUMENTATION LABORATORY COMPANY000200126002016-09-23
08426950513735HemosIL LA Positive ControlINSTRUMENTATION LABORATORY COMPANY000200125002016-09-23
03607450002010STA® - Control LA 1 + 2DIAGNOSTICA STAGO002012016-09-15
00815696021143George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INC5000-250.02020-03-27
00843876000534CRYOcheck Lupus Negative ControlPrecision Biologic IncCCLN-102020-03-06
00843876000541CRYOcheck Lupus Negative ControlPrecision Biologic IncCCLN-052020-03-06
00843876000145CRYOcheck™ Lupus Positive ControlPrecision Biologic IncCCLP-052016-09-23
00843876000152CRYOcheck™ Lupus Positive ControlPrecision Biologic IncCCLP-102016-09-23
00843876000169CRYOcheck™ Weak Lupus Positive ControlPrecision Biologic IncCCWLP-052016-09-23
00843876000176CRYOcheck™ Weak Lupus Positive ControlPrecision Biologic IncCCWLP-102016-09-23
00850201006130LAtrol ABNORMAL CONTROL PLASMABiomedica ADI Inc.816A2016-09-20
00850201006147LAtrol NORMAL CONTROL PLASMABiomedica ADI Inc.816N2016-09-20
00815696020436George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INC5000-0.52016-08-20
00815696020443George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INC5000-1.02016-08-20
00815696020450George King Positive Lupus Anticoagulant GEORGE KING BIO-MEDICAL, INC5000-1.52016-08-20
00815696020849George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INC5000 - bulk2016-08-20
00815696021112George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INC5000 - 100 mL2018-06-22