INTENDED USE

Chlamydia Rapid Test Device is a rapid chromatographic im munoassay for the qualitative detection of Chlamydia trachomatis in clinical specimens to aid in the diagnosis of Chlamydia infection.

M ATERIALS

Materials Provided

1. Test devices
2. Test tubes
3. Dropper tips Sterile polyester tipped applicator (Sterile female cervical swabs)
4. Reagent A
5. Reagent B
6. Workstation
7. Package insert

Materials Required But Not Provided

1. Timer
2. Sterile male cervical swabs
3. Positive control
4. Negative control
5. Urine Cup (for male urine specimens only)
6. Centrifuge tube (for male urine specimens only)

STORAGE & STABILITY

The kit can be stored at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

DIRECTIONS FOR USE