Dna Genetic Analyzer

Product Code: PCA

Clinical Chemistry In Vitro And Other Medical Laser Products

Definition: A Genetic Analyzer Is An Automated Clinical Multiplex Instrument System Intended To Measure And Sort Signals Generated By Multiple Fluorescent Dyes In Order To Analyze Dna/rna Molecules In An Assay From A Clinical Sample. Individual Nucleotide Sequences And Dna Fragment Sizes Are Identified Using Chain- Or Dye-termination Or Dye Primer Cycle Sequen

Applicable Standards: None

Code of Federal Regulations: 862.2570


Radiation TypeOptical
Radition SafetyRadiation E
Annual ReportsRadiation Emitting Electronic Product Codes // Qui

Products Classified as PCA

652Dna Genetic AnalyzerInstrumentation For Clinical Multiplex Test Systems.

Total Product Life Cycle (TPLC) Devices

652Dna Genetic AnalyzerInstrumentation For Clinical Multiplex Test Systems.

FDA Consensus Standards

Dna Genetic Analyzer [33070]21 CFR §862.2570 🔎

Pre-market Notifications for PCA

K191030Applied Biosystems™ 3500 Dx Genetic Analyzer And Applied Biosystems™ 3500xL Dx Genetic AnalyzerLife Technologies Corporation
BK110039510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Life Technologies Corporation

Global Unique Device Identification Database

10190302000192DNA genetic analyzer
10190302000666DNA genetic analyzer
10190302000659DNA genetic analyzer
10190302000642DNA genetic analyzer
10190302000277DNA genetic analyzer
10190302000260DNA genetic analyzer
10190302000253DNA genetic analyzer
10190302000215DNA genetic analyzer
10190302000208DNA genetic analyzer
10190302000673DNA genetic analyzer
10190302000246DNA genetic analyzer
10190302000178DNA genetic analyzer
10190302000154DNA genetic analyzer
10190302015066DNA genetic analyzer
10190302014052DNA genetic analyzer

Maude Adverse Events

VITAGENE DNA TESTVITAGENE2020-01-06
NIPTPANOROMA2015-10-29
3500 XL DX GENETIC ANALYZER CS2LIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-03-27
3500 XL DX GENETIC ANALYZER CS2LIFE TECHNOLOGIES HOLDINGS PTE. LTD2014-03-06
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