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Performance Test Kit BACTEC™ 460



Cat. # Description Qty. Unit
440534 Performance Test Kit BACTEC™ 460
1 EA
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Intended Use:

To provide an overall performance and calibration test for the BACTEC™ 460TB instrument, and to set forth appropriate radiation safety precautions and to suggest instructions for the handling, use, storage and disposal of the radioactive material.


Catalog # Description Quantity Unit
440534 Performance Test Kit BACTEC™ 460
1 EA

BD BACTEC™ PTK Performance Test Kit
Revision: 2010/07     Revision Date: 07/01/2010    

Intended Use:

To provide an overall performance and calibration test for the BACTEC™ 460TB instrument, and to set forth appropriate radiation safety precautions and to suggest instructions for the handling, use, storage and disposal of the radioactive material.



Product Summary:

The Performance Test Kit provides reagents to evaluate the overall performance and calibration of the BACTEC 460TB instrument. Successful performance of this test assures that the electronics and displays are correctly calibrated and operating properly. Performance of this test verifies that the instrument needles are not clogged and there are no air leaks. The test should be performed daily and the result recorded as part of the Quality Assurance program for the BACTEC 460TB system.



User Quality Control:



Reagents:

The following are included in the BACTEC PTK Performance Test Kit:

11A 14C Solution 1 vial (20 mL) 1 µCi (37 kBq) of 14C radioactive material in bicarbonate solution
11B Test acid 3 vial (10 mL) 2N hydrochloric acid solution


Warnings and Precautions:

For in vitro Diagnostic Use.

This product contains dry natural rubber.

Prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depressed stopper, or leakage. DO NOT USE any vial showing evidence of contamination.

Prior to use, the user should examine the vials for evidence of damage or deterioration. On rare occasions, the glass bottle neck may be cracked and the neck may break during removal of the flip-off cap or in handling. Also, on rare occasions, a vial may not be sealed sufficiently. In both cases the contents of the vials may leak or spill, especially if the vial is inverted.

The Test Acid vials contain strong acid. Flush with water immediately and seek medical assistance if it splashes into mouth or eyes.

To minimize the potential of leakage during inoculation into vials, use syringes with permanently attached needles or Luer-Lok™ brand tips.



Information shown on this page is a short summary extracted from the Package Insert, available as a PDF under the Related Documents section of this page.