FDA.reportPublic FDA data

Emit® 2000 Quinidine Assay

Primary DI
00842768023293
Brand
Emit® 2000 Quinidine Assay
Company
Siemens Healthcare Diagnostics Inc.
Model
10445329
Catalog number
4Q229
Device description
Emit® 2000 Quinidine Assay labeled with the Beckman Coulter® name
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
LBZENZYME IMMUNOASSAY, QUINIDINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBZEnzyme Immunoassay, QuinidineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011605000EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229Syva Co., Dade Behring, Inc.2001-06-12LBZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768023293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768023293008427680232938427680232930842768023293

GMDN Terms#

Term, Definition table
TermDefinition
Quinidine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the cardiovascular drug quinidine in a clinical specimen, using an enzyme immunoassay (EIA) 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)227-8994XX@XX.XX
+1(800)227-8994CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
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
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336147917ONLINE TDM QuinidineRoche Diagnostics GmbHLBZ2021-01-15
00884883005990QMS Quinidine ImmunoassayMicrogenics CorporationLBZ2016-09-26
00842768001048Syva® Emit® 2000 Qunidine AssaySiemens Healthcare Diagnostics Inc.LBZ2016-09-24
00842768001055Syva® Emit® 2000 Quinidine CalibratorsSiemens Healthcare Diagnostics Inc.LBZ2016-09-24
00884883006003QMS Quinidine Immunoassay Calibrator SetMicrogenics CorporationLBZ2016-09-22
04015630999262QuinidineRoche Diagnostics GmbHLBZ2016-09-20
04015630915873QuinidineRoche Diagnostics GmbHLBZ2016-09-20
00380740011215ARCHITECTABBOTT LABORATORIESLBZ2016-06-06
00380740011222ARCHITECTABBOTT LABORATORIESLBZ2016-06-06