FDA.reportPublic FDA data

STA® - Staclot® dRVV Screen 2

Primary DI
13607450003397
Brand
STA® - Staclot® dRVV Screen 2
Company
DIAGNOSTICA STAGO
Model
00339
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K061805000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061805000STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRMDiagnostica Stago, Inc.2006-12-06GIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13607450003397PrimaryGS10
03607450003390Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1360745000339713607450003397
03607450003390036074500033903607450003390

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
262277122
Device count
12
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03607450006766STA® - Coag Control N + ABN006762016-09-15
03607450006773STA® - Coag Control (N + ABN) PLUS006772016-09-15
03607450006780STA® - System Control N + P006782016-09-15
03607450005264STA® - Liatest® Control N + P005262016-09-15
13607450006756STA® - Unicalibrator006752016-09-15
13607450011392Pool Norm011392016-09-15
03607450005400FDP Plasma005402016-09-15
13607450005414FDP Plasma (Latex)005412016-09-15
13607450005513FDP Plasma (Buffer)005512016-09-15
13607450006749STA® - Fibrinogen 5006742016-09-15
03607450589894STA Compact Max® (with cap piercing option)589892016-09-15
03607450589900STA Compact Max®589902016-09-15
03607450590265STA R Max®590262018-10-30
03607450590272STA R Max® (with cap piercing option)590272018-10-30
13607450009757STA® - Desorb U009752020-09-24
03607450009736STA® - Cleaner Solution009732020-09-29
13607450003601STA® - Owren-Koller003602018-09-24
03607450000030STA Coag Expert®V8871112022-12-09
03607450000047Coag.One server licenseV8867652022-12-09
03607450867657Coag.One server licenseV7867652022-12-09

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
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