Phadia 1000 instrument

Part Number 12-3800-01

Immunology and Microbiology Devices

2

No

Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI IL, IN, KS, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.

Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.

All versions of the instrument

Immunology and Microbiology Devices

2

No

Nationwide

Phadia 1000 Instrument, Article Number 12-3800-01.

Phadia 1000 Instrument (Allergy testing system). An in vitro diagnostic medical device (IVD) Part Number: 12-3800-01 ARTG Number: 192561

Phadia 1000 Instrument. An in vitro diagnostic medical device (IVD)Article Number: 12-3800-01All instrument software (ISW) versionsAll Lot/Serial NumbersARTG Number: 192561