FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge LIDO

Primary DI
00842768015281
Brand
Dimension Vista® Flex® reagent cartridge LIDO
Company
Siemens Healthcare Diagnostics Inc.
Model
10445132
Catalog number
K4113
Device description
Lidocaine Flex® reagent cartridge, 60 tests
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
KLRENZYME IMMUNOASSAY, LIDOCAINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLREnzyme Immunoassay, LidocaineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061655000DIMENSION VISTA FLEX REAGENT CARTRIDGESDade Behring, Inc.2006-07-10LDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015281PrimaryGS10
00630414005034Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015281008427680152818427680152810842768015281
00630414005034006304140050346304140050340630414005034

GMDN Terms#

Term, Definition table
TermDefinition
Lidocaine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the cardiovascular drug lidocaine 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
005088112
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31
00630414293752Atellica IM SHBG11206215112062152020-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414220680Atellica CH LIDOSiemens Healthcare Diagnostics Inc.KLR2018-10-08
00842768001390Syva® Emit® Lidocaine AssaySiemens Healthcare Diagnostics Inc.KLR2016-09-24
00842768001406Syva® Emit® Disopyramide AssaySiemens Healthcare Diagnostics Inc.KLR2016-09-24
00842768005305Dimension® Flex® reagent cartridge LIDOSiemens Healthcare Diagnostics Inc.KLR2016-09-24
00884883006072QMS Lidocaine ImmunoassayMicrogenics CorporationKLR2016-09-22
04015630915736LidocaineRoche Diagnostics GmbHKLR2016-09-20
04015630996933ONLINE TDM LidocaineRoche Diagnostics GmbHKLR2016-09-20