FDA.reportPublic FDA data

Emit® 2000 Procainamide Assay

Primary DI
00842768023262
Brand
Emit® 2000 Procainamide Assay
Company
Siemens Healthcare Diagnostics Inc.
Model
10445320
Catalog number
4K229
Device description
Emit® 2000 Procainamide 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
LARENZYME IMMUNOASSAY, PROCAINAMIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAREnzyme Immunoassay, ProcainamideClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010812000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010812000EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229Syva Co., Dade Behring, Inc.2001-04-13LAR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768023262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768023262008427680232628427680232620842768023262

GMDN Terms#

Term, Definition table
TermDefinition
Procainamide 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 procainamide 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
07613336147900ONLINE TDM ProcainamideRoche Diagnostics GmbHLAR2020-03-05
00630414220673Atellica CH PROCSiemens Healthcare Diagnostics Inc.LAR2018-10-08
00842768000980Syva® Emit® 2000 Procainamide AssaySiemens Healthcare Diagnostics Inc.LAR2016-09-24
00842768000997Syva® Emit® 2000 Procainamide CalibratorsSiemens Healthcare Diagnostics Inc.LAR2016-09-24
00842768005282Dimension® Flex® reagent cartridge PROCSiemens Healthcare Diagnostics Inc.LAR2016-09-24
00842768015403Dimension Vista® Flex® reagent cartridge PROCSiemens Healthcare Diagnostics Inc.LAR2016-09-24
04015630999293ProcainamideRoche Diagnostics GmbHLAR2016-09-20
04015630915859ProcainamideRoche Diagnostics GmbHLAR2016-09-20
00884883005617CEDIA N-Acetylprocainamide Assay Microgenics CorporationLAR2016-09-12
00884883005624CEDIA Procainamide AssayMicrogenics CorporationLAR2016-09-12