FDA.reportPublic FDA data

ONLINE DAT Benzodiazepines II

Primary DI
04015630999347
Brand
ONLINE DAT Benzodiazepines II
Company
Roche Diagnostics GmbH
Model
04939417190
Catalog number
04939417190
Published
2023-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JXMEnzyme immunoassay, benzodiazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221765000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221765000ONLINE DAT Benzodiazepines IIRoche Diagnostics2022-12-23JXM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630999347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630999347040156309993474015630999347

GMDN Terms#

Term, Definition table
TermDefinition
Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple benzodiazepines in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
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
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
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONJXM2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONJXM2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONJXM2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXM2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXM2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONJXM2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2019-02-12
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONJXM2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONJXM2018-07-05
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXM2018-05-23
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONJXM2018-05-23
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXM2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONJXM2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONJXM2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONJXM2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONJXM2018-03-23
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONJXM2018-02-13
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.JXM2017-11-15
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXM2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXM2017-10-12
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXM2017-06-29
10694644300663RDSAMERICAN BIO MEDICA CORPORATIONJXM2017-06-08
10694644300670RDSAMERICAN BIO MEDICA CORPORATIONJXM2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2017-06-08
10694644300649RDSAMERICAN BIO MEDICA CORPORATIONJXM2017-04-06