Research and Diagnostic Systems

Basic Information

• Brand Name: Research and Diagnostic Systems
• Primary DI: 20815762020951
• Version / Model: GH00HX
• Catalog Number: GH00HX
• Company Name: RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
• Labeler DUNS: 087248183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-07-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7021316c-0883-4c2e-b736-17412155c923

Device Description

R&D Glu/Hgb: 3 x 1.5mL High Pack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
GGM	Control, Hemoglobin	Hematology	864.8625	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52856	Glucose/haemoglobin (Hb) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose and haemoglobin (Hb) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20815762020951	GS1
Unit of Use	00815762020957	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K993321	000

Device Sizes

Type	Value	Unit	Text
Total Volume	4.5	Milliliter

Storage Conditions

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