Recognition List Number: 009 Publication Date: 03/08/2004
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-92: NCCLS EP09-A2, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. (InVitro Diagnostics)
Date of Standard: 2002. |
| Address of Standards Organization: |
| NATIONAL COMMITTEE FOR CLINICAL LABORATORY STANDARDS (NCCLS) |
| 940 WEST VALLEY ROAD |
| SUITE 1400 |
| WAYNE, PA 19087 |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF IN VITRO DIAGNOSTIC DEVICE EVALUATION AND SAFETY (OIVD) | | DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD) |
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| (2) | OFFICE OF COMPLIANCE (OC) |
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| Devices Affected: |
| In Vitro Diagnostic Devices |
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| Processes Affected: |
| IDE, 510(K), PMA, PDP, HDE |
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| Type of Standard: |
| National, Horizontal |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
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| Relevant Guidance: |
| Class II special control guidance document for B-type natriuretic peptide |
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| FDA Technical Contact: |
| Max Robinowitz, MD |
| FDA/CDRH/OIVD |
| 2098 GAITHER ROAD, HFZ-440 |
| ROCKVILLE, MD 20850 |
| 240/276-0493 ext: 136 |
| Email: MYR@CDRH.FDA.GOV |
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