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U.S. Department of Health and Human Services

Medical Device Recalls

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510(K) Number: K172126
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Product Description
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Recall
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FDA Recall
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Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, 2 11/02/2023 Cepheid
Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only 2 11/02/2023 Cepheid
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