FDA.reportPublic FDA data

DImension Vista® C1 Inhibitor Flex® Reagent Cartridge

Primary DI
00842768006302
Brand
DImension Vista® C1 Inhibitor Flex® Reagent Cartridge
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10445915
Catalog number
K7086
Device description
For the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DBACOMPLEMENT C1 INHIBITOR (INACTIVATOR), ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072965000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072965000DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CONDade Behring, Inc.2007-12-21DBA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768006302PrimaryGS10
00842768020247Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768006302008427680063028427680063020842768006302
00842768020247008427680202478427680202470842768020247

GMDN Terms#

Term, Definition table
TermDefinition
Complement component C1 inhibitor IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade component C1 inhibitor in a clinical specimen, using a nephelometry/turbidimetry method.

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
B1761350Antiserum to Human C1 Esterase InhibitorKENT LABORATORIES INCDBA2016-09-24
05051700010504Human C1 Inactivator BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDDBA2016-09-24
05051700016674Human C1 Inactivator Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDBA2016-09-24
05051700017589Optilite C1 Inactivator KitTHE BINDING SITE GROUP LIMITEDDBA2016-09-24
00842768007323N Antiserum to Human C1-InhibitorSiemens Healthcare Diagnostics Products GmbHDBA2016-09-24
30014613335580MicroVueQUIDEL CORPORATIONDBA2016-09-15