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Code of Federal Regulations
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Subchapter G
Part 493
Subpart K
ECFRc96daead380f6ed
Analytic Systems
493.1250
Condition: Analytic systems.
493.1251
Standard: Procedure manual.
493.1252
Standard: Test systems, equipment, instruments, reagents, materials, and supplies.
493.1253
Standard: Establishment and verification of performance specifications.
493.1254
Standard: Maintenance and function checks.
493.1255
Standard: Calibration and calibration verification procedures.
493.1256
Standard: Control procedures.
493.1261
Standard: Bacteriology.
493.1262
Standard: Mycobacteriology.
493.1263
Standard: Mycology.
493.1264
Standard: Parasitology.
493.1265
Standard: Virology.
493.1267
Standard: Routine chemistry.
493.1269
Standard: Hematology.
493.1271
Standard: Immunohematology.
493.1273
Standard: Histopathology.
493.1274
Standard: Cytology.
493.1276
Standard: Clinical cytogenetics.
493.1278
Standard: Histocompatibility.
493.1281
Standard: Comparison of test results.
493.1282
Standard: Corrective actions.
493.1283
Standard: Test records.
493.1289
Standard: Analytic systems quality assessment.