FDA.reportPublic FDA data

ONLINE TDM Acetaminophen Gen2

Primary DI
04015630935031
Brand
ONLINE TDM Acetaminophen Gen2
Company
Roche Diagnostics GmbH
Model
6769942190
Catalog number
6769942190
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
LDPCOLORIMETRY, ACETAMINOPHEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDPColorimetry, AcetaminophenClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141928000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141928000COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATORRoche Diagnostics Operations (Rdo)2014-11-25DKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630935031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630935031040156309350314015630935031

GMDN Terms#

Term, Definition table
TermDefinition
Acetaminophen IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of acetaminophen in a clinical specimen, using a spectrophotometry 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
00630414654164Atellica CH Acetaminophen (AcetC)Siemens Healthcare Diagnostics Inc.LDP2025-10-15
00628063401314Alinity c AcetaminophenSekisui Diagnostics, LLCLDP2023-05-08
07613336120934ONLINE TDM Acetaminophen Gen.2Roche Diagnostics GmbHLDP2020-03-05
00628063401185Acetaminophen AssaySekisui Diagnostics, LLCLDP2019-10-02
00628063401215Acetaminophen L3K AssaySekisui Diagnostics, LLCLDP2019-10-02
30014613337867TriageQUIDEL CARDIOVASCULAR INC.LDP2018-11-01
30014613337904TriageQUIDEL CARDIOVASCULAR INC.LDP2018-11-01
00630414595894Atellica CH AcetSiemens Healthcare Diagnostics Inc.LDP2017-12-22
00842768001550Syva® Emit® tox™ Acetaminophen AssaySiemens Healthcare Diagnostics Inc.LDP2016-09-24
00842768005787Dimension® Flex® reagent cartridge ACTMSiemens Healthcare Diagnostics Inc.LDP2016-09-24
00842768015014Dimension Vista® Flex® reagent cartridge ACTMSiemens Healthcare Diagnostics Inc.LDP2016-09-24
00842768023330Emit® tox™ Acetaminophen AssaySiemens Healthcare Diagnostics Inc.LDP2016-09-24
00884883001169DRI Acetaminophen Serum Tox AssayMicrogenics CorporationLDP2016-09-24
00884883001176DRI Acetaminophen Serum Tox CalibratorsMicrogenics CorporationLDP2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen ReagentsSiemens Healthcare Diagnostics Inc.LDP2016-09-24
04015630981205AcetaminophenRoche Diagnostics GmbHLDP2016-09-23
00657498000427Acetaminophen Liquicolor®STANBIO LABORATORY, L.P.LDP2016-09-23
00899722002757Alere Triage®Alere San Diego, Inc.LDP2016-09-21
04015630946372AcetaminophenRoche Diagnostics GmbHLDP2016-09-20
00628063400027ACETAMINOPHEN L3KSekisui Diagnostics, LLCLDP2016-09-20
00893038002135Alere Triage®Alere San Diego, Inc.LDP2016-09-19
00628063400034ACETAMINOPHEN L3KSekisui Diagnostics, LLCLDP2016-09-16
05055273208139ACERANDOX LABORATORIES LIMITEDLDP2016-09-09
00380740003661ARCHITECTABBOTT LABORATORIESLDP2016-09-09
15099590229962SynchronBeckman Coulter, Inc.LDP2016-08-24
10758750008339VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LDP2016-08-23