FDA.reportPublic FDA data

CSAII Cyclosporine II

Primary DI
04015630997459
Brand
CSAII Cyclosporine II
Company
Roche Diagnostics GmbH
Model
4340892190
Catalog number
4340892190
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
MKWCYCLOSPORINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKWCyclosporineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P920031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P920031000EMIT 2000 CYCLOSPORINE SPECIFIC ASSAYDade Behring, Inc.1996-10-02MKW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630997459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630997459040156309974594015630997459

GMDN Terms#

Term, Definition table
TermDefinition
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug cyclosporin A or cyclosporine in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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
00869164000079Emit Cyclosporine SampleFUJIREBIO DIAGNOSTICS, INC.MKW2023-12-06
00380740168209Alinity-ArchitectABBOTT LABORATORIESMKW2019-06-14
00630414598727Atellica IM CsASiemens Healthcare Diagnostics Inc.MKW2018-02-06
00630414598741Atellica IM Multi-Diluent 12Siemens Healthcare Diagnostics Inc.MKW2018-02-06
00630414598765Atellica IM CsA PRE PretreatmentSiemens Healthcare Diagnostics Inc.MKW2018-02-06
00842768001451Syva® Emit® 2000 Cyclosporine Specific AssaySiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001468Syva® Emit® 2000 Cyclosporine Specific CalibratorsSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001475Syva® Emit® 2000 Cyclosporine Specific Negative CalibratorSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001482Syva® Emit® Cyclosporine Pretreatment ReagentSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768005268Dimension® Flex® reagent cartridge CSAESiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768015144Dimension Vista® Flex® reagent cartridge CSASiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768016035Dimension Vista® Flex® reagent cartridge CSAESiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768025136Dimension® CSA Flex® reagent cartridgeSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00884883011861CEDIA Cyclosporine-PLUS AssayMicrogenics CorporationMKW2016-09-24
00630414524450ADVIA Centaur® CsASiemens Healthcare Diagnostics Inc.MKW2016-09-24
00630414524474ADVIA Centaur® CsA PRE PretreatmentSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00630414525549ADVIA Centaur® Multi-Diluent 12Siemens Healthcare Diagnostics Inc.MKW2016-09-24
00884883001589CEDIA Cyclosporine PLUS AssayMicrogenics CorporationMKW2016-09-12
00380740081911ARCHITECTABBOTT LABORATORIESMKW2016-09-09
00380740001308ARCHITECTABBOTT LABORATORIESMKW2016-06-06
00380740001315ARCHITECTABBOTT LABORATORIESMKW2016-06-06
00380740001322ARCHITECTABBOTT LABORATORIESMKW2016-06-06