B·R·A·H·M·S PCT Sensitive KRYPTOR Test System
EUDAMEDFDA 510(k)Class C (EU MDR)
Identity
- Trade Name
- B·R·A·H·M·S PCT sensitive KRYPTOR EUDAMED
- Device Name
- B·R·A·H·M·S PCT sensitive KRYPTOR EUDAMED
- Model / Reference
- 825050N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260157632035 EUDAMED
- Basic UDI-DI
- 426015763825BPCTsensKXXAD EUDAMED
- EMDN Code
- W0102069013 PROCALCITONIN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
The B·R·A·H·M·S PCT Sensitive KRYPTOR is a procalcitonin (PCT) assay kit designed for the quantitative detection of PCT in human blood, serum, or plasma. Procalcitonin is a biomarker used to assess bacterial infections, differentiate sepsis from non-infectious inflammation, and guide antibiotic therapy in clinical settings. This device falls under the nomenclature code W0102069013, classifying it as a diagnostic kit for inflammatory response markers.
The PCT Sensitive KRYPTOR is supplied as a professional-use, single-use kit (reference 825050N) and requires near-patient or laboratory testing. It is not sterile and does not utilize animal or human tissues in its composition. The device is authorized under FDA 510(k) clearance and IVDR compliance, with a Basic UDI of 426015763825BPCTsensKXXAD. Storage and handling must adhere to manufacturer guidelines to ensure accuracy and reliability of results.
Frequently asked questions
What clinical scenarios is the B·R·A·H·M·S PCT sensitive KRYPTOR primarily used to evaluate in patients?
The B·R·A·H·M·S PCT sensitive KRYPTOR is designed to measure procalcitonin (PCT) levels in human blood, serum, or plasma. PCT is a biomarker used to assess bacterial infections, differentiate sepsis from non-infectious inflammation, and help guide antibiotic therapy decisions in clinical settings. This makes it particularly useful in scenarios where distinguishing between infectious and non-infectious causes of inflammation is critical.
Is the B·R·A·H·M·S PCT sensitive KRYPTOR kit intended for use in point-of-care or laboratory settings?
The kit is supplied for professional-use testing and is intended for use in either near-patient (point-of-care) or laboratory settings. While it supports near-patient testing, its primary design aligns with laboratory-grade accuracy and reliability, ensuring consistent results for clinical decision-making.
How is the B·R·A·H·M·S PCT sensitive KRYPTOR kit supplied, and is it single-use or reusable?
The kit is supplied as a single-use professional-use device with the reference number 825050N. This means each kit is designed for one-time use only, ensuring sterility and consistency of results per the manufacturer’s guidelines. Reuse is not recommended or supported.
Does the B·R·A·H·M·S PCT sensitive KRYPTOR kit contain any animal or human-derived components?
No, the kit does not utilize animal or human tissues in its composition. This is explicitly stated in the manufacturer’s specifications, ensuring compliance with regulatory requirements for diagnostic assays.
What storage and handling precautions should be taken with the B·R·A·H·M·S PCT sensitive KRYPTOR kit to maintain accuracy?
While the manufacturer’s specific storage guidelines are not detailed in the provided data, the kit’s reliability depends on adherence to standard protocols for diagnostic reagents. It is non-sterile, so exposure to contamination must be avoided. Always follow the manufacturer’s instructions to preserve the integrity of the assay and ensure accurate PCT measurement results.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070310 | Class C | Active |
| FDA 510(k) | United States | FDA_510K | DEN150009 | Class C | Active |
| FDA 510(k) | United States | FDA_510K | K171338 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 426015763825BPCTsensKXXAD | Class C | Active |
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Manufacturer
- Manufacturer
- B·R·A·H·M·S GmbH
- EUDAMED SRN
- DE-MF-000026030
- FDA Applicant
- Brahms Aktiengesellschaft
Sources (2)
- EUDAMED b01a0c23-bbb4-4b4c-9392-e1f2d2f913ee 85 fields · synced Sep 18, 2026
- FDA 510(k) K070310 1 fields · synced May 18, 2026