FDA.reportPublic FDA data

LA 2 Confirmation Reagent

Primary DI
00630414639451
Brand
LA 2 Confirmation Reagent
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873902
Catalog number
10873902
Device description
LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants
Published
2024-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GIRREAGENT, RUSSEL VIPER VENOM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIRReagent, Russel Viper VenomHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013114000
K922156000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013114000BCS SYSTEMDade Behring, Inc.2001-11-09JPA
K922156000LUCOR CONFIRMATORY REAGENTGradipore , Ltd.1993-04-06GIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414639451PrimaryGS10
00842768019661Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414639451006304146394516304146394510630414639451
00842768019661008427680196618427680196610842768019661

GMDN Terms#

Term, Definition table
TermDefinition
Lupus anticoagulant marker 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 qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)242-3233CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414634029INNOVANCE D-Dimer 2.010873803108738032026-08-19
00630414634210INNOVANCE D-Dimer 2.0 Diluent10873807108738072026-08-19
00630414634234INNOVANCE D-Dimer 2.0 Control 310873806108738062026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 210873805108738052026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 110873804108738042026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 110874091108740912026-08-19
00630414656014INNOVANCE D-Dimer 2.010874090108740902026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 210874092108740922026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 310874093108740932026-08-19
00630414656069INNOVANCE D-Dimer 2.0 DILUENT10874094108740942026-08-19
00630414312446N FLC Supplementary Reagent10873769108737692026-06-26
00630414285054N Latex ADNase B (USA)10873691108736912020-07-07
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414639765LA 1 Screening ReagentSiemens Healthcare Diagnostics Products GmbHGIR2024-03-29
00842768019661LA 2 Confirmation ReagentSiemens Healthcare Diagnostics Products GmbHGIR2024-03-29
00842768019654LA 1 Screening ReagentSiemens Healthcare Diagnostics Products GmbHGIR2024-03-29
00842768007477LA 1 Screening ReagentSiemens Healthcare Diagnostics Products GmbHGIR2020-09-24
00842768007491LA 2 Confirmation ReagentSiemens Healthcare Diagnostics Products GmbHGIR2020-09-24
15391521420470TriniCLOT Lupus ScreenTCOAG IRELAND LIMITEDGIR2019-06-28
15391521420487TriniCLOT Lupus ConfirmTCOAG IRELAND LIMITEDGIR2019-06-28
10859394006108LupoTek Detectin VLR 2 DIAGNOSTICS, INC.GIR2016-11-15
10859394006115LupoTek Correctin VLR 2 DIAGNOSTICS, INC.GIR2016-11-15
10859394006122PlasmaCon LAR 2 DIAGNOSTICS, INC.GIR2016-11-15
10859394006139PlasmaCon LAR 2 DIAGNOSTICS, INC.GIR2016-11-15
08426950513704HemosIL dRVVT ScreenINSTRUMENTATION LABORATORY COMPANYGIR2016-09-23
08426950513711HemosIL dRVVT ConfirmINSTRUMENTATION LABORATORY COMPANYGIR2016-09-23
00843876000442CRYOcheck™ LA Check™Precision Biologic IncGIR2016-09-23
00843876000459CRYOcheck™ LA Check™Precision Biologic IncGIR2016-09-23
00843876000466CRYOcheck™ LA Check™Precision Biologic IncGIR2016-09-23
00843876000473CRYOcheck™ LA Check™Precision Biologic IncGIR2016-09-23
00843876000480CRYOcheck™ LA Sure™Precision Biologic IncGIR2016-09-23
00850201006017DVVtest 10Biomedica ADI Inc.GIR2016-09-20
00850201006024DVVconfirm 5Biomedica ADI Inc.GIR2016-09-20
00850201006062DVVtest 25Biomedica ADI Inc.GIR2016-09-20
00850201006123DVVconfirm 10Biomedica ADI Inc.GIR2016-09-20
13607450003335STA® - Staclot® dRVV Screen 5DIAGNOSTICA STAGOGIR2016-09-15
13607450003342STA® - Staclot® dRVV ConfirmDIAGNOSTICA STAGOGIR2016-09-15
13607450003397STA® - Staclot® dRVV Screen 2DIAGNOSTICA STAGOGIR2016-09-15