Devices

Device Recall IRISpec" CA/CB twopart urine chemistry control twin set

Model / Serial
Iris Diagnostics part number 800-0074, lot number 131-12.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. || Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
Manufacturer
Iris Diagnostics
1 Event
- Recall of Device Recall IRISpec" CA/CB twopart urine chemistry control twin set

Manufacturer

Iris Diagnostics

Manufacturer Address
Iris Diagnostics, 9172 Eton Ave, Chatsworth CA 91311-5805
Source
USFDA

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