LA 1 Screening Reagent

Primary DI
00842768019654
Brand
LA 1 Screening Reagent
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873904
Catalog number
10873904
Device description
LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence 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
Rx
false
OTC
false
Sterile
false
Single use
false

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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013114000BCS SYSTEMDade Behring, Inc.2001-11-09JPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414639765PrimaryGS10
00842768019654Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414639765006304146397656304146397650630414639765
00842768019654008427680196548427680196540842768019654

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
388240673
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00842768017742Washing Solution for Coagulation Analyzers10446684OWZC392016-09-24
00842768024887BFT II Analyzer10458677OVKF0322016-09-24
00630414639703Control Plasma P10873891108738912024-02-19
00630414639772Standard Human Plasma10873907108739072024-03-25
00630414640167Dade Ci-Trol Coagulation Control Level 110873842108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, Low10873833108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 210873843108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, High10873834108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 310873844108738442024-03-25
00630414640747Control Plasma N 10873874108738742024-02-19
00842768003899Dade® Ci-Trol® Heparin Control, Low10445715B4224-502016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414639451LA 2 Confirmation ReagentSiemens Healthcare Diagnostics Products GmbHGIR2024-03-29
00630414639765LA 1 Screening ReagentSiemens Healthcare Diagnostics Products GmbHGIR2024-03-29
00842768019661LA 2 Confirmation 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