Accutest iFOB Positive and Negative Hemoglobin Controls

Basic Information

• Brand Name: Accutest iFOB Positive and Negative Hemoglobin Controls
• Primary DI: 10763924607058
• Version / Model: CSC67
• Company Name: JANT PHARMACAL CORPORATION
• Labeler DUNS: 797393659
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-12
• Public Version: 1
• Public Version Date: 2019-11-20
• Public Version Status: New
• Public Device Record Key: b49ecb6e-d9fb-4c29-a7d4-e1f412aee31c

Device Description

Accutest iFOB Positive and Negative Hemoglobin Controls Contains: 1 positive hemoglobin control and 1 negative hemoglobin control

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
KHE	Reagent, Occult Blood	Hematology	864.6550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54550	Biological fluid occult blood screening 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 biological fluids for the presence of occult blood.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10763924607058	GS1

Premarket Submissions

Submission Number	Supplement Number
K063693	000