Product Comparison


 
Roche 09211101190
BD 441124
BD 441126

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McKesson # 1177911 931480 931479 1174839 1174838
Description 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 BD ProbeTec™ Amplified DNA Assay Neisseria Gonorrhoea For BD Viper™ Instrument 1,152 Tests 1,152 Tests Reagent Kit BD ProbeTec™ Infectious Disease Immunoassay Chlamydia Trachomatis / Neisseria Gohorrhoeae (CT / NG) For BD Viper™ Instrument 1,152 Tests 1,152 Tests Reagent Kit Aspartate Aminotransferase (AST) For use on the ACE Axcel and ACE Alera Clinical Chemistry Systems 450 Tests Reagent Kit Alanine Aminotransferase (ALT) For use on the ACE Axcel and ACE Alera Clinical Chemistry Systems 450 Tests
Manufacturer # 09211101190441124441126SA1053SA1052
Brand Cobas® Liat®BD ProbeTec™BD ProbeTec™  
Manufacturer RocheBDBDAlfa WassermannAlfa Wassermann
Invoice ASSAY, SARS COV-2 FLU A/B COBAS LIAT (20TEST/KT)REAGENT KIT, PROBETEC DNA ASSAY GCREAGENT KIT, PROBETEC DNA ASSAY CTREAGENT, AST (450TEST/KT)REAGENT, ALT (450TEST/KT)
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Comparison

Container Type Tube
Country of Origin GermanyUnknownUnknownUnited StatesUnited States
For Use With For use on the Cobas® Liat® SystemFor BD Viper™ InstrumentFor BD Viper™ InstrumentFor use on the ACE Axcel and ACE Alera Clinical Chemistry SystemsFor use on the ACE Axcel and ACE Alera Clinical Chemistry Systems
Number of Tests 20 Tests1,152 Tests1,152 Tests450 Tests450 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 90 daysMcKesson Acceptable Dating: we will ship >= 30 daysMcKesson Acceptable Dating: we will ship >= 30 daysMcKesson Acceptable Dating: we will ship >= 90 daysMcKesson Acceptable Dating: we will ship >= 90 days
Sample Type Nasal Swab / Nasopharyngeal Swab SampleUrine / Endocervical Swab / Vaginal Swab / Male Urethral Swab SamplesUrine / Endocervical Swab / Vaginal Swab / Male Urethral Swab Samples
Storage Requirements Requires RefrigerationUSP Controlled Room TemperatureRequires RefrigerationRequires Refrigeration
Test Name SARS-CoV-2 & Influenza A / BNeisseria GonorrhoeaChlamydia Trachomatis / Neisseria Gohorrhoeae (CT / NG)Aspartate Aminotransferase (AST)Alanine Aminotransferase (ALT)
Test Type Molecular Diagnostic / Real Time RT-PCRAmplified DNA AssayInfectious Disease Immunoassay
Time To Results 20 Minute Results
Type Amplified DNA Assay
UNSPSC Code 4111614441116011411160114111610541116105
Volume 1,152 Tests1,152 Tests
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
  • Qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens
  • Qualitative detection of Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens