FDA.reportPublic FDA data

Procainamide

Primary DI
04015630999293
Brand
Procainamide
Company
Roche Diagnostics GmbH
Model
4490975190
Catalog number
4490975190
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K060773000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060773000ONLINE TDM PROCAINAMIDERoche Diagnostics Corp.2006-08-23LAR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630999293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630999293040156309992934015630999293

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

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

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
00842768023262Emit® 2000 Procainamide AssaySiemens Healthcare Diagnostics Inc.LAR2016-09-24
04015630915859ProcainamideRoche Diagnostics GmbHLAR2016-09-20
00884883005617CEDIA N-Acetylprocainamide Assay Microgenics CorporationLAR2016-09-12
00884883005624CEDIA Procainamide AssayMicrogenics CorporationLAR2016-09-12