Alere OratectCheck OC-001

GUDID 00817405020201

Positive and Negative Oral Fluid Controls

Instant Technologies, Inc.

Multiple drugs of abuse IVD, calibrator

• Primary Device ID: 00817405020201
• NIH Device Record Key: 0a1e6170-ab5b-4fef-a14f-9d923009c307
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere OratectCheck
• Version Model Number: OC-001
• Catalog Number: OC-001
• Company DUNS: 019410187
• Company Name: Instant Technologies, 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: 1-800-340-4029
• Email: xxx@xx.xx
• Phone: 1-800-340-4029
• Email: xxx@xx.xx
• Phone: 1-800-340-4029
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817405020201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103227

FDA Product Code

• DIF: Drug Mixture Control Materials

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

Devices Manufactured by Instant Technologies, Inc.

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• 10817405024084 - iScreen™ Urine Test E-Z Split Key™ Drug Screen Cup: 2024-07-24 iScreen 10 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+++(AMP/COC)+(MET/MOP/PCP)+(BZO/MTD/BAR)
• 10817405024107 - iScreen™ Urine Test E-Z Split Key™ Drug Screen Cup: 2024-07-24 iScreen 8 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+++(MET/OPI/PCP)+(BZO/MTD/BAR)
• 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