iCassette ABTDFYW11201A

GUDID 30817405024026

CLIA Waived FTY/FYL 1ng/ml Cassette

Instant Technologies, Inc.

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• Primary Device ID: 30817405024026
• NIH Device Record Key: 7d0b433e-8971-463e-a713-8d1ca57d3c8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCassette
• Version Model Number: ABTDFYW11201A
• Catalog Number: ABTDFYW11201A
• Company DUNS: 019410187
• Company Name: Instant Technologies, Inc.
• Device Count: 25
• 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: false
• OTC Over-The-Counter: true

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817405024025 [Primary]
GS1	10817405024022 [Unit of Use]
GS1	30817405024026 [Package]; Contains: 00817405024025; Package: Master Carton [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233417

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

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: 2023-12-08
• Device Publish Date: 2023-11-30

Devices Manufactured by Instant Technologies, Inc.

• 30817405024033 - iScreen™: 2024-01-05 9 Panel Privacy EUO Oral Fluid COC20, OPI40, MDMA50, OXY20, THC40, 6AM/HRN10, MET50, AMP50, PCP10
• 30817405024040 - iScreen™: 2024-01-05 11 Panel Privacy EUO Oral Fluid BUP5, AMP50, MDMA50, COC20, OXY20, BAR50, OPI40, BZO10, MET50, MTD30, THC40
• 30817405024057 - iScreen™: 2023-12-15 5 Panel Privacy EUO Oral Fluid MET50, OXY20, OPI40, AMP50, COC20
• 30817405024064 - iScreen™: 2023-12-15 6 Panel Masked EUO Oral Fluid AMP50, THC40, OXY20, COC20, MET50, OPI40
• 30817405024026 - iCassette: 2023-12-08CLIA Waived FTY/FYL 1ng/ml Cassette
• 30817405024026 - iCassette: 2023-12-08 CLIA Waived FTY/FYL 1ng/ml Cassette
• 30817405024002 - iScreen™: 2023-06-02 5 panel CLIA Waived Urine Dip Card AMP1000, COC300,OPI2000,PCP25,THC50
• 30817405024019 - iScreen™: 2023-06-02 5 panel CLIA Waived Urine Dip Card AMP1000, COC300, MET1000, OPI2000, THC50
• 30817405023814 - iScreen™: 2023-05-09 12 Panel CLIA Waived Flat Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TH