AllergiEnd ST-9 1001-36

GUDID B6821001360

36 Well Test Tray

MEDSCIENCE RESEARCH GROUP, INC.

General laboratory assay tray

• Primary Device ID: B6821001360
• NIH Device Record Key: 2923802c-d67d-409d-90f5-4a40396ddca0
• Commercial Distribution Discontinuation: 2021-08-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AllergiEnd ST-9
• Version Model Number: 1001-36
• Catalog Number: 1001-36
• 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: false
• 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: 5614990411
• Email: marvin.smollar@medscienceinc.c
• Phone: 5614990411
• Email: marvin.smollar@medscienceinc.c
• Phone: 5614990411
• Email: marvin.smollar@medscienceinc.com
• Phone: 5614990411
• Email: marvin.smollar@medscienceinc.com
• Phone: 5614990411
• Email: marvin.smollar@medscienceinc.com
• Phone: 5614990411
• Email: marvin.smollar@medscienceinc.com
• Phone: 5614990411
• Email: marvin.smollar@medscienceinc.com
• Phone: 5614990411
• Email: marvin.smollar@medscienceinc.com
• Phone: 5614990411
• Email: marvin.smollar@medscienceinc.com
• Phone: 5614990411
• Email: marvin.smollar@medscienceinc.com
• Phone: 5614990411
• Email: marvin.smollar@medscienceinc.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B6821001360 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-01-08
• Device Publish Date: 2018-11-30

On-Brand Devices [AllergiEnd ST-9]

• B6821001360: 36 Well Test Tray
• B68210010: 72 Well Test Tray
• B682100040: AllergiEnd® ST-9TM Multiple Skin Test Applicator packaged as a single unit of 4 applicators.
• B6821000121: Asymmetric Multiple Skin Testing Device for Percutaneous Skin Testing, 12 applicators individual
• B68210000: The AllergiEnd ST-9 Multiple skin Test Applicator has nine (9) test heads arranged in an asymmet