ProScreen PSD-5N

GUDID 00858998006814

Drugs of Abuse Test Card, AMP/COC/OPI2000/PCP/THC

Instant Tech Subsidiary Acquisition

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• Primary Device ID: 00858998006814
• NIH Device Record Key: e6e70fc1-85cb-4866-8e00-497eb0a5f031
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProScreen
• Version Model Number: PSD-5N
• Catalog Number: PSD-5N
• Company DUNS: 080317182
• Company Name: Instant Tech Subsidiary Acquisition
• 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: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx
• Phone: 1-888-669-4337
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858998006814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113046

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

On-Brand Devices [ProScreen]

• 00858998006999: Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr,
• 00858998006982: Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl
• 00858998006975: Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MDMA+MTD
• 00858998006968: Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BUP+BZO+OPI300 with C
• 00858998006951: Drugs of Abuse Test Card, (BZO/BAR)+(MET1000/OPI2000)+(PCP/AMP)+COC+MDMA+MTD+THC
• 00858998006944: Drugs of Abuse Test Card, (BZO/BAR)+(OXY/MDMA)+(PCP/AMP)+COC150+MET500+OPI300+THC
• 00858998006937: Drugs of Abuse Test Card, (BZO/BAR)+(COC/THC)+(OXY/MDMA)+AMP+MTD+OPI300+PPX
• 00858998006920: Drugs of Abuse Test Card, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+MTD
• 00858998006913: Drugs of Abuse Test Card, (BZO/BAR)+(MET1000/OPI2000)+(PCP/AMP)+COC+THC
• 00858998006906: Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+BUP+MET+OPI300+OXY
• 00858998006890: Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+BZO+MTD+PCP
• 00858998006883: Drugs of Abuse Test Card, (BZO/BAR)+(MET1000/OPI2000)+COC+OXY+THC
• 00858998006876: Drugs of Abuse Test Card, (BZO/BAR)+(MET1000/OPI2000)+AMP+COC+THC
• 00858998006869: Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+BUP+OPI300+OXY
• 00858998006852: Drugs of Abuse Test Card, (COC/THC)+THC+BZO+MTD+OPI300+OXY
• 00858998006845: Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+COC+PCP+THC
• 00858998006838: Drugs of Abuse Test Card, (MET1000/OPI2000)+BZO+COC+OXY+THC
• 00858998006821: Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+BZO+COC+THC
• 00858998006814: Drugs of Abuse Test Card, AMP/COC/OPI2000/PCP/THC
• 00858998006807: Drugs of Abuse Test Card, COC/MET1000/OPI2000/PCP/THC
• 00858998006791: Drugs of Abuse Test Card, BZO/COC/MET1000/OPI2000/THC
• 00858998006784: Drugs of Abuse Test Card, AMP/COC/MET1000/OPI2000/THC
• 00858998006777: Drugs of Abuse Test Card, AMP/BZO/COC/OPI2000/THC
• 00858998006760: Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BAR+BZO+BUP
• 00858998006753: Drugs of Abuse Test Cassette, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G.
• 00858998006746: Drugs of Abuse Test Cassette, (BAR/BZO)+(COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+MTD+PPX
• 00858998006739: Drugs of Abuse Test Cassette, (BAR/BZO)+(COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+MTD+MDMA
• 00858998006722: Drugs of Abuse Test Cassette, (COC/THC)+(MET1000/OPI2000)+AMP
• 00858998006715: Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+MTD+PPX with Cr,
• 00858998006708: Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+AMP+BUP with Cr,
• 00858998006692: Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+BAR+BZO+COC+THC
• 00858998006685: Drugs of Abuse Cup, CLIA Waived, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP
• 00858998006678: Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with Cr
• 00858998006661: Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH,
• 00858998006654: Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+AMP+MTD+OXY+PPX with Cr, Ni, pH, Bl, S
• 00858998006647: Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+MTD with Cr, Ni, pH, Bl
• 00858998006630: Drugs of Abuse Test Card, (MET1000/OPI2000)+BAR+BZO+COC+OXY+THC
• 00858998006623: Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MTD
• 00858998006616: Drugs of Abuse Cup, CLIA Waived, AMP/COC/MDMA/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G.
• 00858998006609: Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G.
• 00858998006593: Drugs of Abuse Cup, CLIA Waived, AMP/BZO/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
• 00858998006586: Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni,
• 00858998006579: Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
• 00858998006562: Drugs of Abuse Cup, (BAR/BZO)+(COC/THC)+(OXY/MDMA)+AMP+MET1000+MTD+OPI300
• 00858998006555: Drugs of Abuse Cup, (BZO/BAR)+(MET1000/OPI2000)+(PCP/AMP)+COC+MDMA+MTD+THC
• 00858998006548: Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET/OPI)+(OXY/MDMA)+AMP+BUP
• 00858998006531: Drugs of Abuse Cup, CLIA Waived, (MET1000/OPI2000)+AMP+BAR+BZO+COC+PCP+THC
• 00858998006524: Drugs of Abuse Cup, CLIA Waived, AMP/BZO/COC/MET1000/OPI2000/THC
• 00858998006517: Drugs of Abuse Cup, CLIA-Waived, AMP/BZO/COC/OPI2000/OXY/THC
• 00858998006500: Drugs of Abuse Cup, CLIA-Waived, AMP/COC/MET1000/OPI2000/THC