B.R.A.H.M.S PCT sensitive KRYPTOR

GUDID 04260157638259

B.R.A.H.M.S GmbH

Procalcitonin (PCT) IVD, kit, fluorescent immunoassay

• Primary Device ID: 04260157638259
• NIH Device Record Key: 89009b8c-f36c-4804-8d9d-1d7bc2a8abde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B.R.A.H.M.S PCT sensitive KRYPTOR
• Version Model Number: 825.050
• Company DUNS: 343844205
• Company Name: B.R.A.H.M.S GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260157638259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150009
• Premarket Notification: K171338

FDA Product Code

• PMT: Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

Devices Manufactured by B.R.A.H.M.S GmbH

• 04260157632127 - B.R.A.H.M.S CgA II KRYPTOR: 2023-10-02
• 04260157632288 - B.R.A.H.M.S CgA II KRYPTOR CAL: 2023-06-28
• 04260157632295 - B.R.A.H.M.S CgA II KRYPTOR QC: 2023-06-28
• 04260157632158 - B.R.A.H.M.S sFlt-1 KRYPTOR: 2023-05-30
• 04260157632196 - B.R.A.H.M.S PlGF plus KRYPTOR: 2023-05-30
• 04260157632455 - B.R.A.H.M.S PlGF plus KRYPTOR CAL: 2023-05-29
• 04260157632462 - B.R.A.H.M.S PlGF plus KRYPTOR QC: 2023-05-29
• 04260157632479 - B.R.A.H.M.S sFlt-1 KRYPTOR CAL: 2023-05-29