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

GUDID 04260157632882

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

Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control Procalcitonin (PCT) IVD, control

• Primary Device ID: 04260157632882
• NIH Device Record Key: 41e4ead5-e78e-481f-be22-078b3aaf2c7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B.R.A.H.M.S PCT sensitive KRYPTOR QC
• Version Model Number: 82592
• 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	04260157632882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150009

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)
• 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