CatScreen™ Z110

GUDID 00819398027267

CatScreen™, rapid test for Moraxella (Branhamella) catarrhalis (M. cat.)using butyrate esterase, 25 disks tests per package Rapid test for the detection of the enzyme butyrate esterase in bacteria isolated on culture media for the presumptive identification of Branhamella (Moraxella) catarrhalis. Performs a butyrate test within 5 minutes. Simply moisten disk, inoculate with organism, then wait for the development of a red color.

HARDY DIAGNOSTICS

Multiple aerobic gram positive bacteria species culture isolate identification IVD, reagent

• Primary Device ID: 00819398027267
• NIH Device Record Key: d8b019a8-c33f-49a5-8b00-987af34ee78f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CatScreen™
• Version Model Number: Z110
• Catalog Number: Z110
• Company DUNS: 039981550
• Company Name: HARDY DIAGNOSTICS
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819398027267 [Unit of Use]
GS1	00819398028554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960996

FDA Product Code

• JTO: Discs, Strips And Reagents, Microorganism Differentiation

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: 2020-07-17
• Device Publish Date: 2020-07-09

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