iScreen™ TDOA-XC10A

GUDID 00817405021383

iScreen™ Urine Test Visual X Drug Screen Cup 10 Panel with Adulterants E&I (OX/pH/CR)(AMP500/BAR300/BZO300/THC50/COC150/MTD300/MET500/OPI2000/OXY100/PCP25)

Instant Technologies, Inc.

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• Primary Device ID: 00817405021383
• NIH Device Record Key: b890e944-e479-4bee-8272-f0a9bcb17e5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iScreen™
• Version Model Number: TDOA-XC10A
• Catalog Number: TDOA-XC10A
• Company DUNS: 019410187
• Company Name: Instant Technologies, Inc.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817405021383 [Unit of Use]
GS1	10817405021380 [Primary]

FDA Product Code

• PUX: Test, Amphetamine, Employment And Insurance Testing, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-08
• Device Publish Date: 2021-05-31

On-Brand Devices [iScreen™]

• 00817405021321: iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/TCA/TH
• 00817405021314: iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/TCA/TH
• 00817405021307: iScreen™ Urine Test Drug Screen Test Card - Methamphetamine (MET)
• 00817405021383: iScreen™ Urine Test Visual X Drug Screen Cup 10 Panel with Adulterants E&I (OX/pH/CR)(AMP500/B
• 10817405022219: iSCREEN™ E&I Oral Fluid Test Drug Screen Swab (AMP50/COC20/MET50/OPI40/PCP10/THC40)
• 10817405022202: iSCREEN™ E&I Oral Fluid Test Drug Screen Swab (AMP50/COC20/MET50/OPI40/PCP10)
• 10817405022226: iScreen™ Urine Test CLIA Waived DX Drug Screen Square Cup 10 panel with SVTs (AMP1000/BAR300/
• 30817405023579: 10 PANEL E&I OF CUBE AMP50/BAR20/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10/THC40
• 30817405023562: 9 PANEL E&I OF CUBE AMP50/BAR20/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10
• 30817405023555: 7 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/OXY20/PCP10/THC40
• 30817405023548: 6 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/OXY20/PCP10
• 30817405023531: 6 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/PCP10/THC40
• 30817405023524: 6 PANEL E&I OF CUBE AMP50/BAR20/COC20/OPI40/PCP10/THC40
• 30817405023517: 5 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/PCP10
• 30817405023500: 5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR,OX,SG)
• 30817405023494: 5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50
• 30817405023487: 10 PANEL 510(K) SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, P
• 30817405023470: 10 PANEL 510(K) SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, P
• 30817405023463: 10 PANEL CLIA WAIVED DIP CARD AMP1000, BAR300, BUP10, BZO300, COC300, MET1000, MTD300, OPI2000,
• 30817405023456: 12 PANEL CLIA WAIVED DIP CARD AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300,
• 30817405023449: 12 PNL CLIA WVD COMP ROUND CUP AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300,
• 30817405023432: 14 PANEL CLIA WAIVED ROUND CUP AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,PPX,TCA,THC SVT (Cr,
• 30817405023425: 7 PANEL CLIA WAIVED ROUND CUP AMP1000, COC300, MET500, MOP300, OXY100, PCP25, THC50 SVT (CR, NI,
• 30817405023418: 10 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000
• 30817405023401: 14 PNL CLIA WAIVED SQUARE CUP AMP500, BAR300, BUP10, BZO300, COC150, MDMA500, MET500, MOP300, MT
• 30817405023395: 5 PANEL CLIA WAIVED SQUARE CUP AMP500, BZO300, COC150, MET500, MOP300 SVT (CR,pH,S.G.)
• 30817405023388: 12 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300,
• 30817405023371: 12 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300
• 30817405023364: 12 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300,
• 30817405023357: 11 PNL CLIA WAIVED SQUARE CUP AMP 500, BAR 300, BUP 10, BZO 300, COC 150, MDMA 500, MET 500, MO
• 30817405023340: 10 PNL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300,
• 30817405023333: 7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MOP300, OXY100, THC50
• 30817405023326: 7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BZO300, COC300, MET1000, MOP300, OXY100, THC50 SVT (CR,O
• 30817405023319: 4 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000
• 30817405023296: 5 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR, NI, OX, pH, S.G
• 30817405023289: 10 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000
• 30817405023272: 10 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BUP10, BZO300, COC300, MET1000, MOP300, MTD300, O
• 30817405023265: 7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,
• 30817405023258: 6 PANEL CLIA WAIVED SQUARE CUP AMP1000, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,S.G.)
• 10817405023247: 12 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300,
• 30817405021476: iScreen BAR Panel(Urine) 25T
• 30817405021582: iScreen DOA Multi-Panel(Urine) 25T
• 30817405021575: iScreen DOA Multi-Panel(Urine) 25T
• 30817405021568: iScreen DOA Multi-Panel(Urine) 25T
• 30817405021551: iScreen DOA Multi-Panel(Urine) 25T
• 10817405022523: iScreen COT Dev(Oral Fluid) 25T
• 30817405022503: iScreen DOA Multi-Panel(Urine) 25T
• 30817405022497: iScreen DOA Multi-Panel(Urine) 25T
• 30817405022480: iScreen DOA Multi-Panel(Urine) 25T
• 30817405022473: iScreen MET Panel(Urine) 25T