ImmuTest Drugs of Abuse Screen Card IMDA-5M

GUDID 00816565020113

AMP/COC/MET1000/OPI2000/THC multiple drugs dipcard with Cr, Ni, pH, Bl, S.G. adulteration tests

AMEDITECH INC.

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

• Primary Device ID: 00816565020113
• NIH Device Record Key: bf27344b-b15a-4fe2-8769-cdf13ee0c9a9
• Commercial Distribution Discontinuation: 2018-06-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ImmuTest Drugs of Abuse Screen Card
• Version Model Number: IMDA-5M
• Catalog Number: IMDA-5M
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816565020113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113046

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

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: 2016-09-01

On-Brand Devices [ImmuTest Drugs of Abuse Screen Card]

• 00816565021288: Immutest MET+THC Test Card with Cr, Ni, pH, Bl, S.G. adulteration test
• 00816565021271: Immutest MET+THC Test Card
• 00816565020113: AMP/COC/MET1000/OPI2000/THC multiple drugs dipcard with Cr, Ni, pH, Bl, S.G. adulteration tests
• 00816565020106: COC/MET1000/THC multiple drugs dipcard with Cr, Ni, pH, Bl, S.G. adulteration tests
• 00816565020090: BUP/MTD/OPI300/OXY/PPX multiple drugs dipcard
• 00816565020083: (BZO/BAR)+(COC/THC)+(PCP/AMP)+MET1000+TCA multiple drugs dipcard
• 00816565020076: (BZO/BAR)+(COC/THC)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+ MET1000 + OPI300 multiple drugs dipcard
• 00816565020069: THC single drug dipcard
• 00816565020052: Opiate 300 single drug dipcard
• 00816565020045: Methamphetamine single drug dipcard
• 00816565020038: Cocaine single drug dipcard
• 00816565020021: Benzodiazepine single drug dipcard
• 00816565020014: Barbiturate single drug dipcard
• 00816565020007: Amphetamine single drug dipcard