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Biotime Sars CoV-2 IgG/IgM Positive Control Pouch 1/Bx

1392509 Horiba Medical - 5300000979

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Price

$ 202.99
Green Info

This item can only be sold to licensed practitioner or any other person(s) or entity licensed by the State.

Green Info

This item is a professional use item. If your State License number is on file, we can ship this item to you. Otherwise, please include your State License number in the comments section of the order.

Green Info

This product is a non stock item that must be ordered from the manufacturer, and as such, will appear on a separate order & will follow at a later date. Item is non-returnable.

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This product is a refrigerated product and will be shipped separately. Refrigerated items do not ship on Friday unless prior arrangements are made for Saturday delivery.

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Please note this item may ship standard ground delivery service. If you need priority delivery on this item, please remove the item from the cart and call 800-372-4346 to speak with a sales representative who can assist in having this item expedited from the manufacturer if possible.

Green Info

This product is a control, not the test. This control is to be used with the appropriate Emergeny Use Authorization Test Kit. See attached documents: Emergency Use Authorization letter, Instruction for use, Healthcare Provider and Patient Fact Sheets.

Description

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Biotime Sars CoV-2 IgG/IgM Positive Control Pouch 1/Box
BX
This Item Is A Control For Use With The Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test. That Test Has Not Been FDA Cleared Or Approved; It Has Been Authorized By FDA Under An EUA For Use By Authorized Laboratories (i.e., Laboratories Certified Under The Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42 U.S.C. 263a, That Meet Requirements To Perform Moderate Or High Complexity Tests); It Has Been Authorized Only For The Presence Of IgM And IgG Antibodies Against SARS-CoV-2, Not For Any Other Viruses Or Pathogens; And It 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. § 360bbb-3(b)(1), Unless The Authorization Is Terminated Or Revoked Sooner.

Category
Infectious Diseases
UNSPSC Taxonomy
41116100- MANUAL TEST KITS AND QUALITY CONTROLS AND CALIBRATORS AND STANDARDS


105CV53_US_MSDS_01.pdf
105CV53_US_MSDS_01.pdf
PDF
105CV53_US_MSDS_01.pdf

Item

Pouch

Item Type

Sars CoV-2 IgG/IgM

Brand

Biotime

Quantity

1/Box

Level

Positive Control