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Cue Health C2110 COVID-19 Control Swab Set
Medical Diagnostic & Emergency / Laboratory - Medical / 1387516 | CUE HEALTH, INC. - C2110
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Category: Medical Diagnostic & Emergency
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Cue Health COVID-19 Pos/Neg Control Swab Set 6/Pk
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Category:
Medical Diagnostic & Emergency
/
Laboratory - Medical
/
Rapid Diagnostic Test Kits
/
Infectious Diseases
UNSPSC:
41116100
Additional attributes
Cue Health COVID-19 Pos/Neg Control Swab Set 6/Pk
1387516
| CUE HEALTH, INC. - C2110
Description:
Cue Health COVID-19 Pos/Neg Control Swab Set 6/Package
Category:
Medical Diagnostic & Emergency
/
Laboratory - Medical
UNSPSC:
41116100
Packaging Options (
1
)
Discontinued
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Product Overview
Product feature summary
• This Test Has Not Been FDA Cleared Or Approved;
• This Test Has Been Authorized By FDA Under An EUA For Use By Authorized Laboratories. Authorized Laboratories Are Laboratories Certified Under The Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42 U.S.C. õ263a, That Meet The Requirements To Perform High, Moderate Or Waived Complexity Tests. This Test Is 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.
• This Test Has Been Authorized Only For The Detection Of Nucleic Acid From SARS-CoV-2, Not For Any Other Viruses Or Pathogens; And
• This Test Is Only Authorized For The Duration Of The Declaration That Circumstances Exist Justifying The Authorization Of Emergency Use Of In Vitro Diagnostics For Detection And/or Diagnosis Of COVID-19 Under Section 564(b)(1) Of The Act, 21 U.S.C. õ 360bbb-3(b)(1), Unless The Authorization Is Terminated Or Revoked Sooner.
Specifications
Product specifications and dimensions
Brand
Cue Health
Item
Control Swab Set
Item Type
COVID-19
Level
Pos/Neg
Quantity
6/Package
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