Product Classification

• Device: blood, occult, colorimetric, in urine
• Regulation Description: Occult blood test.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: JIO
• Submission Type: 510(k)
• Regulation Number: 864.6550
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• CLSI/NCCLS GP14-A 1996 Labeling of Home-Use In Vitro Testing Products; Approved Guideline

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.