federal_register: 00-10876
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 00-10876 | Notice of Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity | Notice | Regulations at 42 CFR 493.15 and 493.17, implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578 (codified at 42 U.S.C. 263a), require that the Secretary provide for the categorization of specific laboratory test systems, assays, and examinations by level of complexity. The criteria for such categorizations also are set forth in those regulations. This Notice announces the addition of: approximately 1,130 test systems, assays, and examinations categorized by CDC as moderate or high complexity with categorization notification to manufacturers between September 4, 1999 and January 31, 2000; and 46 test systems, assays, and examinations CDC determined as waived with notification to manufacturers between September 4, 1999 and February 28, 2000. HHS invites comments on the tests initially categorized in this Notice and reserves the right to reevaluate and recategorize tests based on the comments received in response to this Notice. | 2000-05-03 | 2000 | 5 | https://www.federalregister.gov/documents/2000/05/03/00-10876/notice-of-specific-list-for-categorization-of-laboratory-test-systems-assays-and-examinations-by | https://www.govinfo.gov/content/pkg/FR-2000-05-03/pdf/00-10876.pdf | Health and Human Services Department; Centers for Disease Control and Prevention | 221,44 | Regulations at 42 CFR 493.15 and 493.17, implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578 (codified at 42 U.S.C. 263a), require that the Secretary provide for the categorization of specific laboratory test... |