FDA.reportPublic FDA data

Elecsys sFlT-1

Primary DI
07613336230671
Brand
Elecsys sFlT-1
Company
Roche Diagnostics GmbH
Model
09015353160
Catalog number
09015353160
Published
2025-04-07
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
QWHPrognostic test for development or progression of preeclampsia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWHPrognostic Test For Development Or Progression Of PreeclampsiaClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241453000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241453000Elecsys sFlt-1 and Elecsys PlGFRoche Diagnostics2025-02-07QWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336230671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336230671076133362306717613336230671

GMDN Terms#

Term, Definition table
TermDefinition
Placental growth factor (PLGF) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of placental growth factor (PLGF) in a clinical specimen, using a chemiluminescent immunoassay 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
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
07613336172094Elecsys sFlT-1Roche Diagnostics GmbHQWH2025-04-07
07613336172124Elecsys PlGFRoche Diagnostics GmbHQWH2025-04-07
07613336230756Elecsys PlGFRoche Diagnostics GmbHQWH2025-04-07
04260157632158B.R.A.H.M.S sFlt-1 KRYPTORB.R.A.H.M.S GmbHQWH2023-05-22
04260157632196B.R.A.H.M.S PlGF plus KRYPTORB.R.A.H.M.S GmbHQWH2023-05-22