B.R.A.H.M.S sFlt-1 KRYPTOR

Basic Information

• Brand Name: B.R.A.H.M.S sFlt-1 KRYPTOR
• Primary DI: 04260157632158
• Version / Model: 845075N
• Company Name: B.R.A.H.M.S GmbH
• Labeler DUNS: 343844205
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-22
• Public Version: 1
• Public Version Date: 2023-05-30
• Public Version Status: New
• Public Device Record Key: eb7e46bf-decb-4df1-a19a-779de137c009

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QWH	Prognostic Test For Development Or Progression Of Preeclampsia	Clinical Chemistry	862.1602	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61185	Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of soluble vascular endothelial growth factor receptor 1 (sVEGFR-1), also known as soluble fms-like tyrosine kinase 1 (sFlt-1), in a clinical specimen using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260157632158	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN220027	000