510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OHQClass I

Multi-Analyte Controls Unassayed

21 CFR 862.1660 / Clinical Chemistry
FDA source (opens on fda.gov)

OHQ is the FDA product code for Multi-Analyte Controls Unassayed, a class I device type, regulated under 21 CFR 862.1660. FDA's definition for this code reads: "A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used...". As of , FDA records hold no 510(k) clearances under this code and 24 recalls.

Classification record

Product code
OHQ
Device name
Multi-Analyte Controls Unassayed
FDA definition
A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls.
Regulation
21 CFR 862.1660
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
No
Ingested clearances
0
Ingested recalls
24

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 43 companies shown, in name order