Diamedix

Basic Information

• Brand Name: Diamedix
• Primary DI: 00817273020372
• Version / Model: 720-700
• Company Name: DIAMEDIX CORPORATION
• Labeler DUNS: 151765328
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 4
• Public Version Date: 2018-10-05
• Public Version Status: Update
• Public Device Record Key: ae396f54-1732-4d1a-90fd-c0394336c51f

Device Description

"720-700 anti-dsDNA Test Kit"

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Immunology	866.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30623	Nucleic acid hybridization detection IVD, kit	A collection of reagents and other associated materials intended to be used for the detection of nucleic acid (e.g., DNA, RNA) probes [not included] hybridized to their target nucleotide sequences in a clinical specimen. It may be based on different techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH), or line probe assay (LPA)] and is used to detect and localize the presence or absence of specific nucleic acid sequences.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817273020372	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K994424	000

Storage Conditions

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