FDA.reportPublic FDA data

ACTISCREEN XL-FDP

Primary DI
00850201006116
Brand
ACTISCREEN XL-FDP
Company
Biomedica ADI Inc.
Model
800DB
Catalog number
800DB
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
DAPFIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850201006116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850201006116008502010061168502010061160850201006116

GMDN Terms#

Term, Definition table
TermDefinition
D-dimer IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen, using an agglutination method.

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
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
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
00816870023878D-Dimer AccuLite CLIA Test System - 192 WellsMONOBIND, INC.DAP2024-09-13
00816870023885D-Dimer AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DAP2024-09-13
00816870023892D-Dimer AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DAP2024-09-13
00816870023908D-Dimer AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DAP2024-09-13
00630414639666INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00842768019265INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640181INNOVANCE D-Dimer ControlsSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640488INNOVANCE D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640501INNOVANCE D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
05056080501666Thrombo-Wellcotest Glycine SalineREMEL EUROPE LIMITEDDAP2021-07-21
08426951391615HemosIL D-Dimer HS 500INSTRUMENTATION LABORATORY COMPANYDAP2019-06-10
00895160002502Fluoro-CheckTM D-DimerNANO-DITECH CORPORATIONDAP2019-05-24
30014613337959TriageQUIDEL CARDIOVASCULAR INC.DAP2018-11-01
30014613338000TriageQUIDEL CARDIOVASCULAR INC.DAP2018-11-01
30014613338017TriageQUIDEL CARDIOVASCULAR INC.DAP2018-11-01
00817089020542DiazymeDIAZYME LABORATORIES, INC.DAP2016-11-03
00893038002326Alere Triage®Alere San Diego, Inc.DAP2016-09-26
00899722002733Alere Triage®Alere San Diego, Inc.DAP2016-09-26
00899722002740Alere Triage®Alere San Diego, Inc.DAP2016-09-26
B1761070Antiserum to Human FibrinogenKENT LABORATORIES INCDAP2016-09-24
05056080500041NAREMEL EUROPE LIMITEDDAP2016-09-24
05056080500058NAREMEL EUROPE LIMITEDDAP2016-09-24
00842768003967Dade® DIMERTEST® Latex AssaySiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768003974Dade® DIMERTEST® Latex BeadsSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768004575Acute Care™ D-DIMER CalPakSiemens Healthcare Diagnostics Inc.DAP2016-09-24
00842768004582Stratus® CS Acute Care™ DDMR DilPakSiemens Healthcare Diagnostics Inc.DAP2016-09-24
00842768022814INNOVANCE® D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768022821INNOVANCE® D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768023668INNOVANCE® D-Dimer ControlsSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768027611INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24