Coagulase Cryo™ Z202

GUDID 00819398026574

Coagulase Cryo™, frozen rabbit plasma for tube or slide coagulase test for Staphylococcus aureus detection, 0.5ml fill, 2ml vial, 20 per package The ready-to-use Coagulase Cryo is used to differentiate Staphylococcus species based on the ability to produce coagulase. It contains rabbit plasma, and is used to test for the production of free coagulase. The tube coagulase test is used to identify pathogenic staphylococci. The Staphylococcus species that are capable of producing coagulase include S. aureus (potentially pathogenic in humans and animals) and the animal isolates S. intermedius and S. hyicus.

HARDY DIAGNOSTICS

Coagulase production microbial reagent IVD

• Primary Device ID: 00819398026574
• NIH Device Record Key: 292c50f1-6fae-41d0-9fab-6c2e003c5608
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coagulase Cryo™
• Version Model Number: Z202
• Catalog Number: Z202
• Company DUNS: 039981550
• Company Name: HARDY DIAGNOSTICS
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -2 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819398026574 [Unit of Use]
GS1	00819398026581 [Primary]

FDA Product Code

• JTL: Plasma, Coagulase, Human, Horse And Rabbit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-14
• Device Publish Date: 2020-08-06

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