FDA.reportPublic FDA data

LAtrol NORMAL CONTROL PLASMA

Primary DI
00850201006147
Brand
LAtrol NORMAL CONTROL PLASMA
Company
Biomedica ADI Inc.
Model
816N
Catalog number
816N
Published
2016-09-20
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
GIZPLASMA, CONTROL, NORMAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIZPlasma, Control, NormalHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850201006147PrimaryGS10
10850201006144Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850201006147008502010061478502010061470850201006147
1085020100614410850201006144

GMDN Terms#

Term, Definition table
TermDefinition
Lupus anticoagulant marker IVD, controlA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080600606
Device count
10
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850201006017DVVtest 108108102016-09-20
00850201006024DVVconfirm 58158152016-09-20
00850201006031ACTICHROME Heparin (Anti-FIIa)8208202016-09-20
00850201006048IMUBIND PLASMA PAI-1 ELISA8228222016-09-20
00850201006055ACTICLOT dPT8248242016-09-20
00850201006062DVVtest 258258252016-09-20
00850201006079ACTICHROME HEPARIN (ANTI-FXA)8328322016-09-20
00850201006086ACTICHROME ATIII KIT8388382016-09-20
00850201006093IMUBIND vWF ACTIVITY ELISA8858852016-09-20
00850201006109SPECTROLYSE PAI-11012011012012016-09-20
00850201006116ACTISCREEN XL-FDP800DB800DB2016-09-20
00850201006123DVVconfirm 10815L815L2016-09-20
00850201006130LAtrol ABNORMAL CONTROL PLASMA816A816A2016-09-20
00850201006154ACTICLOT PROTEIN S843L843L2016-09-20
00850201006161ACTICLOT C KITACC-45ACC-452016-09-20
00850201006178DIMERTEST Latex assayDLHK7DLHK72016-09-20
00850201006185XL-FDP agglutination reagent800DB-LX800DB-LX2016-09-20
00850201006192ACTICLOT Protein C Resistance Kit8408402016-09-20
00850201006208ACTICLOT Protein C Resistance control plasmas840C840C2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10859394006061PlasmaCon NR 2 DIAGNOSTICS, INC.GIZ2016-11-15
10859394006078PlasmaCon L1R 2 DIAGNOSTICS, INC.GIZ2016-11-15
10859394006085PlasmaCon L2R 2 DIAGNOSTICS, INC.GIZ2016-11-15
00842768006821Berichrom® Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGIZ2016-09-24
00842768006876Berichrom® Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGIZ2016-09-24
00843876000053CRYOcheck™ Reference Control NormalPrecision Biologic IncGIZ2016-09-23
00843876000060CRYOcheck™ Reference Control NormalPrecision Biologic IncGIZ2016-09-23
00845275000559Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIZ2016-09-16
13607450006756STA® - UnicalibratorDIAGNOSTICA STAGOGIZ2016-09-15
15391521420777TriniCHECK™ D-Dimer 1TCOAG IRELAND LIMITEDGIZ2016-09-12
M52553010Coagulation S.A.C.-1 (Specialty Assay Control)HELENA LABORATORIES CORPORATIONGIZ2016-09-07
00855360006243REAADS Coagulation Control 1CORGENIX MEDICAL CORPORATIONGIZ2016-07-14