BDX 4.55% 10.5¢ bcal diagnostics limited

"Do they not need TGA CE and FDA approvals?" Does anyone have a...

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    "Do they not need TGA CE and FDA approvals?"

    Does anyone have a definite answer to this? I don't think I've ever seen the company mention FDA/TGA/CE, I see they're now talking NATA accreditation though. Certainly no expert in the field but it would seem unusual to me that FDA/TGA/CE approval wasn't required for such important medical tests?
 
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