FDA.reportPublic FDA data

ACTICLOT Protein C Resistance Kit

Primary DI
00850201006192
Brand
ACTICLOT Protein C Resistance Kit
Company
Biomedica ADI Inc.
Model
840
Catalog number
840
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
GGWTEST, TIME, PARTIAL THROMBOPLASTIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGWTest, Time, Partial ThromboplastinHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850201006192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850201006192008502010061928502010061920850201006192

GMDN Terms#

Term, Definition table
TermDefinition
Activated protein C resistance ratio (APCR) IVD, kit, clottingA collection of reagents and other associated materials intended to be used to determine the activated protein C resistance ratio (APCR) of a clinical specimen, using a clotting method to measure clotting time with and without added activated protein C.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080600606
Device count
1
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
00850201006147LAtrol NORMAL CONTROL PLASMA816N816N2016-09-20
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
00850201006208ACTICLOT Protein C Resistance control plasmas840C840C2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414640242Dade Actin FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00630414640327Dade Actin FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00630414640341Dade Actin FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00630414640358Dade Actin FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00630414639758Factor V LeidenSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00842768019562Dade Actin FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00842768019555Dade Actin FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
13607450012627PTT-LADIAGNOSTICA STAGOGGW2021-03-23
03607450012620PTT-LADIAGNOSTICA STAGOGGW2021-03-23
07640175460013PefakitPentapharm AGGGW2017-01-25
10859394006016Phospholin ES w/ Calcium ChlorideR 2 DIAGNOSTICS, INC.GGW2016-11-15
10859394006146LupoTek KCTR 2 DIAGNOSTICS, INC.GGW2016-11-15
10859394006238Phospholin ES w/CalciumR 2 DIAGNOSTICS, INC.GGW2016-11-15
00842768003844Dade® Actin® FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
00842768003868Dade® Actin® FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
00842768003875Dade® Actin® FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
00842768003882Dade® Actin® FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
00842768033520Factor V LeidenSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
08426950076100Coatest APC Resistance V-SINSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950060017Coatest APC Resistance VINSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950060147Coatest APC ResistanceINSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950062424HemosIL Factor V Leiden (APC Resistance V)INSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950087656HemosIL Factor V Reagent Plasma (for APC R V)INSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950088912Coatest APCR Control Plasma Level 1INSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950088929Coatest APCR Control Plasma Level 2INSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
00843876000435CRYOcheck™ Platelet LysatePrecision Biologic IncGGW2016-09-23
03607450005974STA® - C.K. Prest® 5DIAGNOSTICA STAGOGGW2016-09-15
13607450005957STA® - PTT A 5DIAGNOSTICA STAGOGGW2016-09-15
13607450005995PTT-LADIAGNOSTICA STAGOGGW2016-09-15
M52551870AB-TROL 2 Coagulation ControlHELENA LABORATORIES CORPORATIONGGW2016-09-07