Product Comparison


 

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Roche 09211101190
Clinical Diagnostic Solutions 501-263

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McKesson # 894110 1177911 696309 1174838 1174839
Description Reagent Kit Hepatic / General Chemistry Gamma Glutamyl Transferase (GGT) 1 X 120 mL Reagent Kit Cobas® Liat® Molecular Diagnostic / Real Time RT-PCR SARS-CoV-2 & Influenza A / B For use on the Cobas® Liat® System 20 tests Reagent Kit CDS Medonic™ Hematology Lytic Agent For CDS Medonic M Series Hematology Analyzer 1.9 X 8.5 Liter Reagent Kit Alanine Aminotransferase (ALT) For use on the ACE Axcel and ACE Alera Clinical Chemistry Systems 450 Tests Reagent Kit Aspartate Aminotransferase (AST) For use on the ACE Axcel and ACE Alera Clinical Chemistry Systems 450 Tests
Manufacturer # GGT2-12009211101190501-263SA1052SA1053
Brand  Cobas® Liat®CDS Medonic™  
Manufacturer JAS DiagnosticsRocheClinical Diagnostic SolutionsAlfa WassermannAlfa Wassermann
Invoice GGT RGT KIT 1X120ML 1X30ML REAGENTASSAY, SARS COV-2 FLU A/B COBAS LIAT (20TEST/KT)REAGENT SET, CDS/M 8.5L DILUENT 1.9L LYTICREAGENT, ALT (450TEST/KT)REAGENT, AST (450TEST/KT)
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Comparison

Container Type Tube
Country of Origin UnknownGermanyUnited StatesUnited StatesUnited States
For Use With For use on the Cobas® Liat® SystemFor CDS Medonic M Series Hematology AnalyzerFor use on the ACE Axcel and ACE Alera Clinical Chemistry SystemsFor use on the ACE Axcel and ACE Alera Clinical Chemistry Systems
Form Liquid
Number of Tests 20 Tests450 Tests450 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 60 daysMcKesson Acceptable Dating: we will ship >= 90 days
Sample Type Nasal Swab / Nasopharyngeal Swab Sample
Storage Requirements Requires RefrigerationRequires RefrigerationRequires RefrigerationRequires Refrigeration
Test Name Gamma Glutamyl Transferase (GGT)SARS-CoV-2 & Influenza A / BLytic AgentAlanine Aminotransferase (ALT)Aspartate Aminotransferase (AST)
Test Type Hepatic / General ChemistryMolecular Diagnostic / Real Time RT-PCRHematology
Time To Results 20 Minute Results
UNSPSC Code 4111600441116144411160084111610541116105
Volume 1 X 120 mL1.9 X 8.5 Liter
Application Reagent KitReagent KitReagent KitReagent KitReagent Kit
Features and Benefits
  • The cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test is for use on the cobas Liat System under FDA Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Emergency use of this test is limited to authorized laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests
  • The cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System is also authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
  • The new cobas SARS-CoV-2 & Influenza A/B test analyzes nucleic acids from nasopharyngeal and nasal swab samples and self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) to enable frontline healthcare workers to quickly identify and differentiate these similarly presenting infections
  • This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, and influenza B virus and not for any other viruses or pathogens
  • This test is only authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
  • Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
  • Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions
  • Negative results must be combined with clinical observations, patient history, and/or epidemiological information
  • cobas® SARS-CoV-2 & Influenza A/B is intended for use by health professionals or trained operators who are proficient in using the cobas® Liat System
  • The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B virus RNA
  • Contains sufficient reagents to process 20 specimens or quality control samples
  • Kit includes: 20 tests, 20 transfer pipettes, 1 package insert barcode card, cobas Liat Internal Process Control, Proteinase K, cobas Liat Magnetic Glass Particles, Lysis buffer, wash buffer, Elution buffer, A/B Master Mix 1, A/B Master Mix 2, A/B Master Mix 3
  • WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov