FDA.reportPublic FDA data

Nacetylprocainamide

Primary DI
04015630998968
Brand
Nacetylprocainamide
Company
Roche Diagnostics GmbH
Model
4853954190
Catalog number
4853954190
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
LANENZYME IMMUNOASSAY, N-ACETYLPROCAINAMIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LANEnzyme Immunoassay, N-AcetylprocainamideClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060738000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060738000TDM N-ACETYLPROCAINAMIDERoche Diagnostics Corp.2006-08-16LAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630998968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630998968040156309989684015630998968

GMDN Terms#

Term, Definition table
TermDefinition
N-acetylprocainamide 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 N-acetylprocainamide 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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04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
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07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
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07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336147870ONLINE TDM N-acetylprocainamideRoche Diagnostics GmbHLAN2020-03-05
00630414220659Atellica CH NAPASiemens Healthcare Diagnostics Inc.LAN2018-10-08
00842768001017Syva® Emit® 2000 N-Acetylprocainamide CalibratorsSiemens Healthcare Diagnostics Inc.LAN2016-09-24
00842768005299Dimension® Flex® reagent cartridge NAPASiemens Healthcare Diagnostics Inc.LAN2016-09-24
00842768015342Dimension Vista® Flex® reagent cartridge NAPASiemens Healthcare Diagnostics Inc.LAN2016-09-24
00842768017421Syva® Emit® 2000 N-Acetylprocainamide AssaySiemens Healthcare Diagnostics Inc.LAN2016-09-24
00842768023279Emit® 2000 N-Acetylprocainamide AssaySiemens Healthcare Diagnostics Inc.LAN2016-09-24
04015630915750NAcetylProcainamideRoche Diagnostics GmbHLAN2016-09-20