AccuTest-1™

GUDID ALK80001

1 box of 12 Items ALK8002 that contains 432 single head applicators

MEDSCIENCE RESEARCH GROUP, INC.

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• Primary Device ID: ALK80001
• NIH Device Record Key: ae409743-9c68-4f18-9476-4b5e092482e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuTest-1™
• Version Model Number: ALK8004
• Company DUNS: 013114656
• Company Name: MEDSCIENCE RESEARCH GROUP, INC.
• Device Count: 12
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com
• Phone: 561-515-5995
• Email: liz.magdaleno@medscienceinc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 150 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ALK80001 [Unit of Use]
HIBCC	B682ALK8004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172062

FDA Product Code

• LDH: System, Delivery, Allergen And Vaccine

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-24
• Device Publish Date: 2024-04-16

On-Brand Devices [AccuTest-1™]

• B682ALK8002: 36 Single head applicators packed as 4 sets of 9 single head applicators per set
• ALK80001: 1 box of 12 Items ALK8002 that contains 432 single head applicators