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QUANTA Lite® ssDNA ELISA
INOVA DIAGNOSTICS, INC. · Model 708525 · UDI-DI 08426950593744
LJM
Prescription
10
510(k) clearances
0
Adverse events
2
Recalls
26
Facilities
Description
1. 1x ssDNA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ssDNA ELISA Low Positive 4. 1 x1.2mL prediluted ssDNA ELISA High Positive 5. 1 x50mL HRP Sample Diluent 6. 1 x25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-08-27 | Calbiotech Inc | The recall was initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. The firm reported although there is no potential health hazard related to |
| 2008-08-19 | Zeus Scientific Inc | The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266. |
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