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
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
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
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08

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