AccuTest™ Test Tray ALK48T-001

GUDID B682ALK48T001

48 Multiple well test tray

MEDSCIENCE RESEARCH GROUP, INC.

Allergy testing lancet

• Primary Device ID: B682ALK48T001
• NIH Device Record Key: c30bc10d-3e7e-427f-94bc-387d7fc3228e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuTest™ Test Tray
• Version Model Number: ALK48T-001
• Catalog Number: ALK48T-001
• Company DUNS: 013114656
• Company Name: MEDSCIENCE RESEARCH GROUP, INC.
• Device Count: 1
• 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: true
• 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	B682ALK48T001 [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: 2024-03-25
• Device Publish Date: 2024-03-15

On-Brand Devices [AccuTest™ Test Tray]

• B682ALK60T001: 60 Multiple well test tray
• B682ALK48T001: 48 Multiple well test tray