FDA.reportPublic FDA data

Procainamide

Primary DI
04015630915859
Brand
Procainamide
Company
Roche Diagnostics GmbH
Model
20737895322
Catalog number
20737895322
Published
2016-09-20
Public version status
Update
Distribution status
Not 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
K951595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951595000ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESRoche Diagnostic Systems, Inc.1995-09-08CGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630915859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630915859040156309158594015630915859

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336217702Elecsys T309744975190097449751902026-09-04
07613336246672Elecsys Anti-HBc II09745009160097450091602026-09-04
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01

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
04015630999293ProcainamideRoche Diagnostics GmbHLAR2016-09-20
00884883005617CEDIA N-Acetylprocainamide Assay Microgenics CorporationLAR2016-09-12
00884883005624CEDIA Procainamide AssayMicrogenics CorporationLAR2016-09-12