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QBVClass I

Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate

21 CFR 862.2050 / Clinical Chemistry
FDA source (opens on fda.gov)

QBV is the FDA product code for Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate, a class I device type, regulated under 21 CFR 862.2050. FDA's definition for this code reads: "To prepare cell concentrate and/or plasma concentrate by separating cells through centrifugation. Contraindications - Labeling Warnings and Precautions: The safety and effectiveness of this device for in vivo indications for use has not been established". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QBV
Device name
Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
FDA definition
To prepare cell concentrate and/or plasma concentrate by separating cells through centrifugation. Contraindications - Labeling Warnings and Precautions: The safety and effectiveness of this device for in vivo indications for use has not been established.
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code QBV

By decision year
2 clearances under product code QBV with a decision year between 2026 and 2026, 2026 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QBV by decision year
YearClearances
20262

Applicants with the most clearances

Product code QBV
Applicants holding the most 510(k) clearances under product code QBV
ApplicantClearances
Miracell Co.,Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order