Immutest Drugs of Abuse Screen Device IMCA-10MO

GUDID 00816565021516

(COC/THC)+(MET/OPI)+(PCP/AMP)+BAR+BZO+MTD+OXY with Cr, Ni, pH, Bl, S.G. adulteration tests

AMEDITECH INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00816565021516
• NIH Device Record Key: 301da32c-e30a-4f51-aa3a-f9f3f1bd9a97
• Commercial Distribution Discontinuation: 2018-06-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Immutest Drugs of Abuse Screen Device
• Version Model Number: IMCA-10MO
• Catalog Number: IMCA-10MO
• Company DUNS: 010551716
• Company Name: AMEDITECH 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: true
• 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: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx
• Phone: 1-858-535-1968
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816565021516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113046

FDA Product Code

• JXM: Enzyme Immunoassay, Benzodiazepine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-08

On-Brand Devices [Immutest Drugs of Abuse Screen Device]

• 00816565021516: (COC/THC)+(MET/OPI)+(PCP/AMP)+BAR+BZO+MTD+OXY with Cr, Ni, pH, Bl, S.G. adulteration tests
• 00816565021325: ImmuTest (COC/THC)+(PCP/AMP)+BAR+BZO+MET+OPI+TCA
• 00816565021318: Immutest (COC/THC)+(PCP/AMP)+BAR+BZO+MET+OPI+TCA with Cr, Ni, pH, Bl, S.G. adulteration tests
• 00816565021301: AMP+MET+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
• 00816565021295: Immutest AMP+MET+THC