# Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays:  Guidance for Industry and FDA Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/review-criteria-for-assessment-of-c-reactive-protein-crp-high-sensitivity-c-reactive-protein-hscrp-and-cardiac-c-reactive-assays-guidance-for-industry-and-fda-staff/04502e16-fef0-4033-a292-0ec180d25217

> FDA guidance document: Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays:  Guidance for Industry and FDA Staff. Issue date: September 22, 2005. Get complete insights and analysis.

---

## Details

- Title: Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays:  Guidance for Industry and FDA Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2005-09-22
- Last Changed: 2020-03-19
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-0957">FDA-2020-D-0957</a>

## Related Documents

- [Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan (PDF version)](https://www.globalkeysolutions.net/guidances/special-controls-document/class-ii-special-controls-guidance-document-serological-assays-for-the-detection-of-beta-glucan-pdf-version/4fa93abb-1a1e-4d2b-ac9e-eed807e3dfbf)
- [Dental Handpieces - Premarket Notification [510(k)] Submissions:  Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/dental-handpieces-premarket-notification-510k-submissions-guidance-for-industry-and-fda-staff/7aa25e62-346c-4cb8-9791-431db46c770d)
- [The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations:  Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/the-review-and-inspection-of-premarket-approval-application-manufacturing-information-and-operations-guidance-for-industry-and-fda-staff/4055fb7b-9286-4de8-80b0-10744950a3e2)
