FDA.reportPublic FDA data

Elecsys Folate

Primary DI
04015630939695
Brand
Elecsys Folate
Company
Roche Diagnostics GmbH
Model
07027290190
Catalog number
07027290190
Published
2017-04-21
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
CGNACID, FOLIC, RADIOIMMUNOASSAY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGNAcid, Folic, RadioimmunoassayClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141426000ELECSYS FOLATE IIIRoche Diagnostics2014-10-17CGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630939695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630939695040156309396954015630939695

GMDN Terms#

Term, Definition table
TermDefinition
Folate (vitamin B9) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of folate (vitamin B9) in a clinical specimen, using a chemiluminescent 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

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07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
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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
00630414293653Atellica IM FolSiemens Healthcare Diagnostics Inc.CGN2020-05-31
00380740136567AlinityABBOTT IRELANDCGN2019-02-12
00816870020327Folate AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CGN2019-02-11
00816870020334Monobind AccuBind Folate ELISA Kit - 192 WellsMONOBIND, INC.CGN2019-02-11
00816870022000Folate AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CGN2019-02-11
00816870022017Folate AccuLite CLIA Test System -192 WellsMONOBIND, INC.CGN2019-02-11
00630414469454ADVIA Centaur® FOL (25-pack)Siemens Healthcare Diagnostics Inc.CGN2018-12-01
00380740130923AlinityABBOTT IRELANDCGN2018-11-12
00380740136550AlinityABBOTT IRELANDCGN2018-11-12
00630414597690Atellica™ IM RBC FOLSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598963Atellica™ IM FolSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598970Atellica™ IM FolSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598987Atellica™ IM Fol DILSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598994Atellica™ IM Fol MCMSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414599007Atellica™ IM Fol DTT/Releasing AgentSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00817830022597SimulTRAC-SNB Vitamin B12/Folate 125I RIA KitMP BIOMEDICALS, LLCCGN2017-01-09
00817830022603SimulTRAC-S Vitamin B12/Folate 125I RIA KitMP BIOMEDICALS, LLCCGN2017-01-09
00817830022542SimulTRAC-S Vitamin B12/Folate 125I RIA KitMP BIOMEDICALS, LLCCGN2016-10-20
14560189211916AIA-PACK FolateTOSOH CORPORATIONCGN2016-09-24
14560189212005AIA-PACK RBC FOLATETOSOH CORPORATIONCGN2016-09-24
04560189211926AIA-PACK Folate Calibrator SetTOSOH CORPORATIONCGN2016-09-24
04560189211933AIA-PACK Folate Pretreatment SetTOSOH CORPORATIONCGN2016-09-24
04560189211940AIA-PACK Floate Sample Diluting SolutionTOSOH CORPORATIONCGN2016-09-24
04560189212015AIA-PACK RBC FOLATE CALIBRATOR SETTOSOH CORPORATIONCGN2016-09-24
04560189212022AIA-PACK RBC FOLATE HEMOLYZING REAGENT SETTOSOH CORPORATIONCGN2016-09-24
04560189212039AIA-PACK RBC FOLATE PRETREATMENT SETTOSOH CORPORATIONCGN2016-09-24
04560189212046AIA-PACK RBC FOLATE SAMPLE DILUTING SOLUTIONTOSOH CORPORATIONCGN2016-09-24
00842768016653Dimension Vista® Flex® reagent cartridge FOLSiemens Healthcare Diagnostics Inc.CGN2016-09-24
00630414204192ADVIA Centaur® FOLSiemens Healthcare Diagnostics Inc.CGN2016-09-24
00630414208671ADVIA Centaur® FOL MCMSiemens Healthcare Diagnostics Inc.CGN2016-09-24