Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

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Facility	Where	Also makes	Recorded by
CCepheid	Sunnyvale, CA	Assay, Direct, Nucleic Acid Amplification, Influenza Virus · Assay, Enterovirus Nucleic Acid · Bcr/Abl1 Monitoring Test+33 more	federal registry
CCepheid	Lodi, CA	Assay, Direct, Nucleic Acid Amplification, Influenza Virus · Bcr/Abl1 Monitoring Test · C. Difficile Nucleic Acid Amplification Test Assay+31 more	federal registry
DFDiagnostics for the Real World LTD	Morgan Hill, CA	Container, Specimen, Non-Sterile · Monitor,Test,Hiv-1 · Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	federal registry
DMDiasorin Molecular, LLC	Cypress, CA	Antigen, B. Pertussis · Antigen, Cf (Including Cf Control), Epstein-Barr Virus · Anti-Jcv Antibody Detection Assay+37 more	federal registry
TDThe Dot Printer	Irvine, CA	Blood And Urine Collection Kit (Excludes Hiv Testing) · Blood Specimen Collection Convenience Kit (Excludes Hiv) · Blood Specimen Collection Kit (Excludes Hiv Testing)+5 more	federal registry
Abbott Molecular INC.	Des Plaines, IL	Applicator, Absorbent Tipped, Sterile · Assay, Genotyping, Hepatitis C Virus · Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus+42 more	federal registry
LCLuminex CORP	Northbrook, IL	Bordetella Pertussis Dna Assay System · C. Difficile Toxin Gene Amplification Assay · Chlamydophila Pneumoniae Dna Assay System+14 more	federal registry
BDBeckton Dickinson	Sparks, MD	Accessories, Catheter · Acridine Orange · Antigen, B. Pertussis+98 more	federal registry
BDBecton, Dickinson and Company	Sparks Glencoe, MD	Accessories, Catheter · Acridine Orange · Antigen, B. Pertussis+98 more	federal registry
Baebies, INC.	Durham, NC	Alpha-D-Galactosidase A (Gla) Newborn Screening Test System · Alpha-D-Glucosidase (Gaa) Newborn Screening Test System · Alpha-L-Iduronidase (Idua) Newborn Screening Test System+7 more	federal registry
RMRoche Molecular Systems INC.	Branchburg, NJ	Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus · Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis · Babesia Spp. Serological Reagents+44 more	federal registry
NLNuclein, LLC.	Austin, TX	Instrumentation For Clinical Multiplex Test Systems	federal registry
Biofire Defense LLC	Salt Lake City, UT	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays · Bordetella Pertussis Dna Assay System · Chlamydophila Pneumoniae Dna Assay System+12 more	federal registry
Biofire Diagnostics LLC	Salt Lake City, UT	Bordetella Pertussis Dna Assay System · Chlamydophila Pneumoniae Dna Assay System · Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness+18 more	federal registry

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