510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OIBClass I

Blood And Urine Collection Kit (Excludes Hiv Testing)

21 CFR 864.3250 / Pathology
FDA source (opens on fda.gov)

OIB is the FDA product code for Blood And Urine Collection Kit (Excludes Hiv Testing), a class I device type, regulated under 21 CFR 864.3250. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and 28 recalls.

Classification record

Product code
OIB
Device name
Blood And Urine Collection Kit (Excludes Hiv Testing)
FDA definition
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.
Regulation
21 CFR 864.3250
Device class
Class I
Review panel
Pathology
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
29

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order