Hemoglobin FAS Control

Basic Information

• Brand Name: Hemoglobin FAS Control
• Primary DI: 00817869020212
• Version / Model: HC-118
• Catalog Number: HC-118
• Company Name: ANALYTICAL CONTROL SYSTEMS INC
• Labeler DUNS: 038232682
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-31
• Public Version: 1
• Public Version Date: 2019-03-04
• Public Version Status: New
• Public Device Record Key: 35710785-9992-445c-a98e-4532e0b1e8d9

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
KHG	Whole Blood Hemoglobin Determination	Hematology	864.7500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59803	Inherited haemoglobinopathy IVD, control	A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817869020212	GS1
Package	10817869020219	GS1	6 pack	6	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K802569	000