FDA.reportPublic FDA data

ONLINE TDM Carbamazepine Gen.4

Primary DI
07613336121108
Brand
ONLINE TDM Carbamazepine Gen.4
Company
Roche Diagnostics GmbH
Model
08057435190
Catalog number
08057435190
Published
2020-03-05
Public version status
New
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
KLTENZYME IMMUNOASSAY, CARBAMAZEPINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLTEnzyme Immunoassay, CarbamazepineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151578000Carbamazepine Gen 4Roche Diagnostics Operations (Rdo)2015-10-22KLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336121108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336121108076133361211087613336121108

GMDN Terms#

Term, Definition table
TermDefinition
Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug carbamazepine in a clinical specimen, using a nephelometry/turbidimetry 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

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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
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
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842768000928Syva® Emit® Carbamazepine AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768000935Syva® Emit® Carbamazepine CalibratorsSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768001871Syva® Emit® II Plus Barbiturate AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768001888Syva® Emit® II Plus Barbiturate AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768005770Dimension® Flex® reagent cartridge CRBMSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768014352Syva® Emit® II Plus Barbiturate AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768015137Dimension Vista® Flex® reagent cartridge CRBMSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00842768023231Emit® 2000 Carbamazepine AssaySiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414527130ADVIA Centaur® CARBSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414527147ADVIA Centaur® CARB +ZSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414527178ADVIA Centaur® CARB MCMSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414560793ADVIA® Chemistry CARB_2 ReagentsSiemens Healthcare Diagnostics Inc.KLT2016-09-24
00630414961095IMMULITE® 2000 Systems CMP CarbamazepineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLT2016-09-24
00630414963679IMMULITE® / IMMULITE® 1000 Systems CMP CarbamazepineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLT2016-09-24
04015630936885ONLINE TDM Carbamazepine Gen4Roche Diagnostics GmbHKLT2016-09-20
04015630999033CarbamazepineRoche Diagnostics GmbHKLT2016-09-20
00884883001251CEDIA Carbamazepine II AssayMicrogenics CorporationKLT2016-09-12
00380740001834ARCHITECTAbbott GmbHKLT2016-09-09
00380740081072ARCHITECTAbbott GmbHKLT2016-09-09
00380740081935ARCHITECTAbbott GmbHKLT2016-09-09
15099590232184SynchronBeckman Coulter, Inc.KLT2016-08-24
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