FDA.reportPublic FDA data

CoaguChek XS Patient Self Testing Care Kit

Primary DI
00365702125100
Brand
CoaguChek XS Patient Self Testing Care Kit
Company
Roche Diagnostics GmbH
Model
4837738001
Catalog number
04837738001
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GJSTEST, TIME, PROTHROMBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJSTest, Time, ProthrombinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062925000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062925000COAGUCHEK XS SYSTEMRoche Diagnostics Corp.2007-01-29GJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00365702125100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00365702125100003657021251003657021251000365702125100

GMDN Terms#

Term, Definition table
TermDefinition
Home-use/point-of-care coagulation analyser IVD, battery-poweredA battery-powered instrument intended to be used by a layperson in the home or similar environment, or by health professionals at the point-of-care, for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as whole blood prothrombin time (WBPT), whole blood partial thromboplastin time (WBPTT), heparin dose response, activated clotting time (ACT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436540291141microINR® Expert KitILINE MICROSYSTEMS SLGJS2026-04-22
09360136000079 Xprecia Prime™ Coagulation AnalyzerUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
09360136000086 Xprecia Prime™ Coagulation AnalyzerUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
09360136000093Xprecia Prime™ PT/INR Test StripsUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
08436540291134microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-08-02
08436540290915microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-08-02
00850053916205IDG/SanzayIDG/SANZAY CorporationGJS2024-07-03
08436540290908microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-04-01
00630414639871Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414639888Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414639963Thromborel SSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414640006Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019593Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019609Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768018749Thromborel SSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019586Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00850053916182IDG/SanzayIDG/SANZAY CorporationGJS2024-01-12
00054749004782i-STAT PTplus CartridgeAbbott Point of Care Inc.GJS2024-01-10
00054749004843i-STAT PTplus Control Level 1Abbott Point of Care Inc.GJS2024-01-10
00054749004850i-STAT PTplus Control Level2Abbott Point of Care Inc.GJS2024-01-10
00365702702356CoaguChek VantusRoche Diagnostics GmbHGJS2023-12-01
00850040656022Assure PT Care PT/INR Monitoring System COAGUSENSE INC.GJS2023-04-06
00850040656039Assure PT Care Test Strip KitCOAGUSENSE INC.GJS2023-04-06
00860007370861Coag-senseCOAGUSENSE INC.GJS2021-09-30
00860007370878Coag-senseCOAGUSENSE INC.GJS2021-09-30
00861900000398Coag-Sense Test Strip Kit, 50 ct.COAGUSENSE INC.GJS2021-09-09
10861900000395Coag-Sense Test Strip Kit, 50 ct.COAGUSENSE INC.GJS2021-09-09
08436540290717microINR ® CHIPS ILINE MICROSYSTEMS SLGJS2021-05-28
08436540290816microINR ® MeterILINE MICROSYSTEMS SLGJS2021-05-28
08436540290700microINR ® CHIPS ILINE MICROSYSTEMS SLGJS2021-05-28