inforMED
OIBClass I

Blood And Urine Collection Kit (excludes Hiv Testing)

Pathology · 21 CFR 864.3250

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

MDR events7All time
Recalls25All time
Registered firms45Currently listed
510(k) clearances0All time

Recalls

25 recall events for this product code

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510(k) clearances

0 clearances for this product code

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No 510(k) clearances on file for this product code.