E. coliPRO™ PL070HD

GUDID 00819398027953

E. coliPRO™ O157 Latex Kit, rapid latex agglutination test for E. coli O157, 50 tests A rapid latex agglutination test kit for the identification of the E. coli O157 serotype. So sensitive that it requires only one single colony. Uses proprietary antibodies that eliminate the possibility of cross-reactions with Escherichia hermanii and other sorbitol-negative Escherichia species. Contains both positive and negative controls. Includes reaction cards and mixing sticks Each kit contains: E. coliPRO™ O157 Latex Reagent 1 dropper vial/kit E. coliPRO™ O157 Positive Control Suspension 1 dropper vial/kit E. coliPRO™ O157 Negative Control Latex Reagent 1 dropper vial/kit Latex Test Cards 20 cards/kit Mixing Sticks 75 sticks/kit

HARDY DIAGNOSTICS

Escherichia coli antibody IVD, reagent

• Primary Device ID: 00819398027953
• NIH Device Record Key: 31e2302a-e0dd-4b8f-b757-aa7259c2ab3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E. coliPRO™
• Version Model Number: PL070HD
• Catalog Number: PL070HD
• Company DUNS: 039981550
• Company Name: HARDY DIAGNOSTICS
• Device Count: 1
• 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 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	00819398027953 [Primary]

FDA Product Code

• GMZ: Antigens, All Types, Escherichia Coli

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: 2020-09-10
• Device Publish Date: 2020-09-02

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