MiSeqDx Instrument DX|410|1001 Medical Device Identification
MiSeq Dx Instrument - Illumina
Product. Catalog no. MiSeqDx Instrument. DX-410-1001. MiSeqDx Reagent Kit v3. 20037124. Illumina DNA Prep with Enrichment Dx ...
MiSeqDx Instrument | IVD NGS system with global ... - Illumina
With the flexibility to operate in either Research Use Only (RUO) or Dx Mode, the MiSeqDx Instrument can conduct clinical research, develop, and run a range of ...
MiSeqDx Instrument DX-410-1001 Medical Device Identification
GUDID 00816270020002 · The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument ...
Figure 1: MiSeqDx Instrument—The FDA-regulated, CE-IVD– marked MiSeqDx ... Product. Catalog no. MiSeqDx Instrument. DX-410-1001. MiSeqDx Reagent Kit v3.
Device Classification Under Section 513(f)(2)(De Novo)
ILLUMINA MISEQDX PLATFORM. Requester. illumina, inc. 5200 illumina way. san ... device-advice-comprehensive-regulatory-assistance/medical-device-databases ...
MiSeqDx DNA Sequencer from Illumina - Axonia Medical
The MiSeqDx instrument is the first Food and Drug Administration (FDA)-regulated and Conformite Europeene in vitro diagnostic (CE-IVD)-marked platform for NGS.
k123989.pdf - accessdata.fda.gov
The MiSeqDx Platform is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument ...
MiSeqDx Cystic Fibrosis Clinical Sequencing Assay ... - AccessGUDID
DEVICE: MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run) (00816270020026) · Device Identifier (DI) Information · Device Characteristics · GMDN · FDA ...
One platform, the MiSeqDx instrument, runs both the MiSeqDx Cystic Fibrosis 139-Variant Assay and the MiSeqDx Cystic Fibrosis Clinical ...
MiSeqDx System - SelectScience
Designed specifically for the clinical laboratory environment, the MiSeqDx instrument offers a small, approximately 4 square feet (0.37 square meters) footprint ...
ILLUMINA MiSeqDx Instrument | Biotech Lab - Bid on Equipment
The Illumina MiSeq DX is a medical laboratory equipment used for pathology, hematology, oncology, and biological laboratory applications.
Illumina sent you an Urgent Medical Device Recall Notice FSN2023-1338 regarding an issue affecting the NextSeq 550Dx and MiSeqDx instruments.
Illumina Miseq DX Sequencer - IET - Used Lab Equipment
The MiSeqDx instrument is the the first Food and Drug Administration (FDA)-regulated and Conformite Europeene in vitro diagnostic (CE-IVD)-marked platform for ...
NextSeq 550Dx and MiSeqDx Instruments - FirstWord HealthTech
NextSeq™ 550Dx and MiSeq™Dx Instruments - Canada.ca Health product recall Brand(s)
The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have ...
Datasheet Miseqdx Instrument | PDF | Dna Sequencing - Scribd
The document describes the MiSeqDx instrument, the first next-generation sequencing system cleared by the FDA for in vitro diagnostic use.
Illumina Launches NextSeq 550Dx, Expands Use of MiSeqDx
... Dx NGS system with the FDA as a Class II medical device. NextSeq ... Dx for library prep for the instrument. These products replace the ...
MISEQ DX NGS SEQUENCER in Pleasanton, CA, USA - Machinio
General Medical Equipment in USA. Subcategory: Ngs sequencer. Listing ID: 59512407. Description. The MiSeqDx instrument is the first FDA-cleared in vitro ...
Illumina Grows Clinical IVD Portfolio with Introduction of NextSeq ...
The company also announced that the intended use for the MiSeq™Dx instrument ... The expanded intended use of the MiSeqDx instrument, which was ...
MiSeqDX System & MiSeq System (ILLUMINA) - Polo GGB
... instrument. MiSeq is the only benchtop sequencer that can produce 2 x 300 ... This allows assembly of small genomes or detection of target variants with unmatched ...