Analytic Systems

  1. Law
  2. CFR 42
  3. Public Health
  4. Centers for Medicare & Medicaid Services, Department of Health and Human Services
  5. Standards and Certification
  6. Laboratory Requirements
  7. Quality System for Nonwaived Testing
  8. Analytic Systems

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Section
493.1250

Condition: Analytic systems.

Section
493.1251

Standard: Procedure manual.

Section
493.1252

Standard: Test systems, equipment, instruments, reagents, materials, and supplies.

Section
493.1253

Standard: Establishment and verification of performance specifications.

Section
493.1254

Standard: Maintenance and function checks.

Section
493.1255

Standard: Calibration and calibration verification procedures.

Section
493.1256

Standard: Control procedures.

Section
493.1261

Standard: Bacteriology.

Section
493.1262

Standard: Mycobacteriology.

Section
493.1263

Standard: Mycology.

Section
493.1264

Standard: Parasitology.

Section
493.1265

Standard: Virology.

Section
493.1267

Standard: Routine chemistry.

Section
493.1269

Standard: Hematology.

Section
493.1271

Standard: Immunohematology.

Section
493.1273

Standard: Histopathology.

Section
493.1274

Standard: Cytology.

Section
493.1276

Standard: Clinical cytogenetics.

Section
493.1278

Standard: Histocompatibility.

Section
493.1281

Standard: Comparison of test results.

Section
493.1282

Standard: Corrective actions.

Section
493.1283

Standard: Test records.

Section
493.1289

Standard: Analytic systems quality assessment.