FDA.reportPublic FDA data

Lithium

Primary DI
07613336121382
Brand
Lithium
Company
Roche Diagnostics GmbH
Model
08057974190
Catalog number
08057974190
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
NDWAssay, porphyrin, spectrophotometry, lithium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDWAssay, Porphyrin, Spectrophotometry, LithiumClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063684000COBAS LITHIUMRoche Diagnostics Corp.2008-03-21NDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336121382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336121382076133361213827613336121382

GMDN Terms#

Term, Definition table
TermDefinition
Lithium therapeutic drug monitoring IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug lithium 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
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07613336218341Elecsys CA 19-909755608190097556081902026-06-01
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07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
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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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811403010691Lithium ElectrodeDiamond Diagnostics Inc.NDW2023-06-05
00630414287935Atellica CH Lithium_2 (LITH_2)Siemens Healthcare Diagnostics Inc.NDW2020-11-27
00630414288178ADVIA Chemistry Lithium_2 (LITH_2) reagentsSiemens Healthcare Diagnostics Inc.NDW2020-11-27
00380740136277AlinityABBOTT LABORATORIESNDW2018-07-30
00630414006789Atellica CH LiSiemens Healthcare Diagnostics Inc.NDW2017-12-21
00385480167291NOVANOVA BIOMEDICAL CORPORATIONNDW2017-04-24
00842768035326Dimension Vista® Flex® reagent cartridge LITHSiemens Healthcare Diagnostics Inc.NDW2016-09-24
00630414509778ADVIA® Chemistry LITH Lithium ReagentsSiemens Healthcare Diagnostics Inc.NDW2016-09-24
00385480152112NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480152129NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
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00385480539630NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480539647NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
04015630921669LithiumRoche Diagnostics GmbHNDW2016-09-20
04015630032440Lithium ElectrodeRoche Diagnostics GmbHNDW2016-09-20
00385480128827NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
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00385480167284NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
05055273209143Li 2RANDOX LABORATORIES LIMITEDNDW2016-09-16
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