FOBT-CHEK

Basic Information

• Brand Name: FOBT-CHEK
• Primary DI: 00816917025308
• Version / Model: OCQNBRZL
• Company Name: POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
• Labeler DUNS: 078413594
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-11
• Public Version: 1
• Public Version Date: 2021-06-21
• Public Version Status: New
• Public Device Record Key: b78c331d-a962-4864-9232-6adc2116c9a5

Device Description

Negative Control for OC-Auto for Brazil

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OOX	Automated Occult Blood Analyzer	Hematology	864.6550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38218	Faecal occult blood IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816917025308	GS1

Premarket Submissions

Submission Number	Supplement Number
K041408	000
K092330	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius