Others titles
- CLIA Datasets
- Clinical Laboratory Improvement Amendments (CLIA)
Keywords
- CLIA
- Laboratory Tests
- Marketed Laboratory Tests
- CLIA Database
- Laboratory Testing
- Quality Laboratory Testing
Clinical Laboratory Improvement Amendments
The CLIA Database lists records of all commercially marketed laboratory tests that have been categorized under the Clinical Laboratory Improvement Amendments (CLIA), either by the Centers for Disease Control and Prevention (CDC) prior to January 31, 2000 or by the FDA since that date.
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Commercial Use, 
Remix & Adapt, 
White Label
Description
The Clinical Laboratory Improvement Amendments (CLIA) Dataset includes records of all commercially marketed laboratory tests categorized by CDC or FDA.
For each Document Number that refers to 510(k), Premarket approval (PMA), humanitarian device exemption (HDE) or 510(k) exempt number, a Parent Number, Analyte Id and name, a Test System Id and the Specialty Id are listed.
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.
Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control (CDC). Each agency has a unique role in assuring quality laboratory testing.
About this Dataset
Data Info
| Date Created | 2013 |
|---|---|
| Last Modified | 2018-12-24 |
| Version | 2018-12-24 |
| Update Frequency |
Quarterly |
| Temporal Coverage |
N/A |
| Spatial Coverage |
United States |
| Source | John Snow Labs; U.S. Food and Drug Administration (FDA); |
| Source License URL | |
| Source License Requirements |
N/A |
| Source Citation |
N/A |
| Keywords | CLIA, Laboratory Tests, Marketed Laboratory Tests, CLIA Database, Laboratory Testing, Quality Laboratory Testing |
| Other Titles | CLIA Datasets, Clinical Laboratory Improvement Amendments (CLIA) |
Data Fields
| Name | Description | Type | Constraints |
|---|---|---|---|
| Document_Number | Document Number refers to either the 510(k), Premarket approval (PMA), humanitarian device exemption (HDE) or 510(k) exempt number | string | required : 1 |
| Test_System_id | The Test System Id is an internally generated number based on the test system, analyte and categorization | integer | level : Nominalrequired : 1 |
| Test_System_Name | Test System Name | string | required : 1 |
| Qualifier1 | The qualifier field is to expand on the test system for using another manufacturer's reagent on the test system and/or an additional processing step. | string | - |
| Qualifier2 | The qualifier field is to expand on the test system for using another manufacturer's reagent on the test system and/or an additional processing step. | string | - |
| Analyte_id | The Analyte ID is an internally generated number | integer | level : Nominalrequired : 1 |
| Analyte_Name | Analyte Name | string | required : 1 |
| Specialty_id | The Speciality_ID field contains codes that translate to the following Speciality Names: | integer | level : Nominalrequired : 1 |
| Complexity | Complexity of the diagnostic test | string | enum : Array ( [0] => MODERATE [1] => HIGH [2] => WAIVED ) required : 1 |
| Date_Effective | Effective date of the categorization | date | required : 1 |
Data Preview
| Document Number | Test System id | Test System Name | Qualifier1 | Qualifier2 | Analyte id | Analyte Name | Specialty id | Complexity | Date Effective |
| X140005 | 21528 | Carolina Liquid Chemistries Corp., Biolis 24i clinical chemistry analyzer | 12 | Alanine aminotransferase (ALT) (SGPT) | 2 | MODERATE | 2014-03-18 | ||
| X140003 | 22432 | RightBio Metrics, RightSpot Infant pH Indicator | 335 | Gastric pH | 2 | WAIVED | 2014-03-18 | ||
| X140003 | 22433 | RightBio Metrics, RightLevel pH Detector | 335 | Gastric pH | 2 | WAIVED | 2014-03-18 | ||
| X140003 | 22434 | RightBio Metrics, RightSpot pH Indicator | 335 | Gastric pH | 2 | WAIVED | 2014-03-18 | ||
| X140002 | 14778 | Vital Diagnostics, Envoy 500 Chemistry Analyzer | 7 | Protein, total | 2 | MODERATE | 2014-02-25 | ||
| X140001 | 14778 | Vital Diagnostics, Envoy 500 Chemistry Analyzer | 8 | Lactate dehydrogenase (LDH) | 2 | MODERATE | 2014-02-25 | ||
| X130033 | 22319 | The Binding Site Spaplus Analyzer | 5 | Albumin | 2 | MODERATE | 2014-01-28 | ||
| X130032 | 22235 | Bio-Rad Laboratories Inc., UriSelect⢠4 Medium | For Isolation and Differentiation of Urinary Tract Pathogens | 142 | Aerobic organisms from urine specimens only | 8 | HIGH | 2013-12-13 | |
| X130032 | 22236 | Bio-Rad Laboratories Inc., UriSelect⢠4 Medium | For Enumeration of Urinary Tract Pathogens | 142 | Aerobic organisms from urine specimens only | 8 | MODERATE | 2013-12-13 | |
| X130029 | 22116 | Carolina Liquid Chemistries CLC 720 Chemistry Analyzer | 842 | Gamma glutamyl transferase (GGT) | 2 | MODERATE | 2013-11-07 |
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