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Moreover, the applicant provided that, of the 2.2 million flexible cystoscopy procedures furnished annually, 23 percent are performed with single-use, disposable cystoscopes, further, single-use, disposable cystoscopes are used in at least 500 hospitals and clinics, including 35 to 50 academic medical centers

Each vial is individually labeled with a unique Lot Number for quality control and traceability

They are not intended to represent clinical evidence in humans, and 5-Amino-1MQ has not been approved by the FDA, EMA, or any other regulatory authority for any indication

The difference is substantial but not insurmountable