CoaguStaph™

Basic Information

• Brand Name: CoaguStaph™
• Primary DI: 00816576028207
• Version / Model: Z003
• Catalog Number: Z003
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2020-06-25
• Public Version: 1
• Public Version Date: 2020-07-03
• Public Version Status: New
• Public Device Record Key: 7f211613-79e9-486a-92f7-a46fdbbf28bb

Device Description

CoaguStaph™, Rabbit Coagulase Plasma with EDTA, freeze dried, coagulase test for Staphylococcus aureus, 6x3ml Lyophilized rabbit plasma, for the identification of Staphylococcus aureus by the coagulase test. EDTA helps eliminate false positives, not recommended for germ tubes, packaged in a glass serum vial with a rubber septum and aluminum crimp seal.

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: Yes
• 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
JTL	Plasma, Coagulase, Human, Horse And Rabbit	Microbiology	866.2160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42737	Coagulase production microbial reagent IVD	A substance or reactant intended to be used in microbial testing to detect the enzyme coagulase, produced by a microorganism isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816576028191	GS1
Primary	00816576028207	GS1

Customer Contacts

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

Storage Conditions

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