Recognition List Number: 016 Publication Date: 11/03/2006
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-7: CLSI / NCCLS LA1-A2 1994, Assessing the Quality of Radioimmunoassay Systems - Second Edition; Approved Guideline. (InVitro Diagnostics)
Date of Standard: 1994. |
| Addresses of Standards Organizations: |
| CLINICAL LABORATORY STANDARDS INSTITUTE (CLSI) |
| 940 WEST VALLEY ROAD |
| SUITE 1400 |
| WAYNE, PA 19087 |
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| 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 DEVICE EVALUATION (ODE) | | DIVISION OF CLINICAL LABORATORY DEVICES (DCLD) |
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| (2) | OFFICE OF COMPLIANCE (OC) | | |
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| Devices Affected: |
| All Radioimmunoassay Systems |
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| Processes Affected: |
| Manufacturing/Devices Evaluation (510(k), PMA, PDP, IDE) |
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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: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
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