FDA.reportPublic FDA data

Dimension Vista®a1-Antitrypsin Flex® reagent cartridge

Primary DI
00842768005992
Brand
Dimension Vista®a1-Antitrypsin Flex® reagent cartridge
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10445884
Catalog number
K7014
Device description
For the quantitative measurement of a1-antitrypsin in human serum and plasma on the Dimension Vista® System
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DEMALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEMAlpha-1-Antitrypsin, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063610000DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGHDade Behring, Inc.2007-01-11DEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768005992PrimaryGS10
00842768019876Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005992008427680059928427680059920842768005992
00842768019876008427680198768427680198760842768019876

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-1-antitrypsin (protease inhibitor) in a clinical specimen, using a nephelometry/turbidimetry method. Alpha-1-antitrypsin deficiency is typically associated with liver cirrhosis and pulmonary emphysema.

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)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00842768003905Dade® Ci-Trol® Heparin Control, High10445716B4224-602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051700010696Human Alpha 1 Antitrypsin NL BINDARID™ KitTHE BINDING SITE GROUP LIMITEDDEM2023-06-29
07613336130230Tina-quant a1-Antitrypsin ver.2Roche Diagnostics GmbHDEM2020-03-05
00380740156299ARCHITECTABBOTT LABORATORIESDEM2020-03-03
00380740156374ARCHITECTABBOTT LABORATORIESDEM2020-03-03
00380740156411ARCHITECTABBOTT LABORATORIESDEM2020-03-03
00380740153519AlinityABBOTT LABORATORIESDEM2019-01-04
00630414596228Atellica CH AATSiemens Healthcare Diagnostics Inc.DEM2017-12-19
00817302023152CLC720 Chemistry Analyzer w/ISECAROLINA LIQUID CHEMISTRIES CORPORATIONDEM2016-12-19
15099590010607AUBECKMAN COULTER IRELAND INC.DEM2016-09-24
B1761220Antiserum to Alpha 1 AntitrypsinKENT LABORATORIES INCDEM2016-09-24
05051700016421Human alpha 1 antitrypsin Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDEM2016-09-24
05051700017763Optilite Alpha-1-antitrypsin KitTHE BINDING SITE GROUP LIMITEDDEM2016-09-24
00842768009921N Antiserum to Human a1-AntitrypsinSiemens Healthcare Diagnostics Products GmbHDEM2016-09-24
00842768009938N Antiserum to Human a1-AntitrypsinSiemens Healthcare Diagnostics Products GmbHDEM2016-09-24
00630414517728ADVIA® Chemistry AAT Alpha-1-Antitrypsin ReagentsSiemens Healthcare Diagnostics Inc.DEM2016-09-24
04015630916597Tinaquant 1Antitrypsin ver2Roche Diagnostics GmbHDEM2016-09-20
04015630928415Tinaquant 1Antitrypsin ver2Roche Diagnostics GmbHDEM2016-09-20
04015630927562Albumin BCPRoche Diagnostics GmbHDEM2016-09-20
04015630906758Tina-quant alpha1-AntitrypsinRoche Diagnostics GmbHDEM2016-09-20
00816426020009K-ASSAY® Alpha-1 AT ReagentKAMIYA BIOMEDICAL COMPANY, LLCDEM2016-09-16
00380740030131ARCHITECTABBOTT LABORATORIESDEM2016-09-09
00380740044862ARCHITECTABBOTT LABORATORIESDEM2016-09-09
00380740054151ARCHITECTABBOTT LABORATORIESDEM2016-09-09
15099590224042IMMAGEBeckman Coulter, Inc.DEM2016-08-24
10758750002290VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DEM2016-08-23