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

Blood Detection Capsule

21 CFR 876.1390 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QUD is the FDA product code for Blood Detection Capsule, a class II device type, regulated under 21 CFR 876.1390. FDA's definition for this code reads: "Ingestible gastrointestinal blood detection capsule device is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QUD
Device name
Blood Detection Capsule
FDA definition
Ingestible gastrointestinal blood detection capsule device is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract.
Regulation
21 CFR 876.1390
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QUD

By decision year
1 clearance under product code QUD with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QUD by decision year
YearClearances
20231

Applicants with the most clearances

Product code QUD
Applicants holding the most 510(k) clearances under product code QUD
ApplicantClearances
Enterasense Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code