AccuTest-8™ ALK08H-006

GUDID B682ALK08H006

8 Head Multiple-Skin Testing Applicators packed 6 to the vacuum tray

MEDSCIENCE RESEARCH GROUP, INC.

Allergy testing lancet

• Primary Device ID: B682ALK08H006
• NIH Device Record Key: a5b1d537-170a-4838-960c-5dedc16ec049
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuTest-8™
• Version Model Number: ALK08H-006
• Catalog Number: ALK08H-006
• 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	B682ALK08H006 [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

Devices Manufactured by MEDSCIENCE RESEARCH GROUP, INC.

• ALK80001 - AccuTest-1™: 2024-04-24 1 box of 12 Items ALK8002 that contains 432 single head applicators
• B682ALK08H006 - AccuTest-8™: 2024-03-258 Head Multiple-Skin Testing Applicators packed 6 to the vacuum tray
• B682ALK08H006 - AccuTest-8™: 2024-03-25 8 Head Multiple-Skin Testing Applicators packed 6 to the vacuum tray
• B682ALK10H006 - AccuTest-10™: 2024-03-25 10 Head multiple-skin testing applicators packed 6 to the vacuum tray
• B682ALK48T001 - AccuTest™ Test Tray: 2024-03-25 48 Multiple well test tray
• B682ALK60T001 - AccuTest™ Test Tray: 2024-03-25 60 Multiple well test tray
• B682ALK8002 - AccuTest-1™: 2024-03-25 36 Single head applicators packed as 4 sets of 9 single head applicators per set
• B68280021 - ST-9: 2021-10-08 Allergy Testing Lancet
• B68210010 - AllergiEnd ST-9: 2019-01-08 72 Well Test Tray