Immunalysis 652OF-0500

GUDID 00840937114629

SEFRIA™ Hydrocodone Oral Fluid

IMMUNALYSIS CORP

Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840937114629
• NIH Device Record Key: af5d7176-c356-4155-a32f-938532d73e11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immunalysis
• Version Model Number: 652OF-0500
• Catalog Number: 652OF-0500
• Company DUNS: 002804244
• Company Name: IMMUNALYSIS CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840937114629 [Primary]

FDA Product Code

• PVH: Test, opiates, 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: 2024-04-29
• Device Publish Date: 2024-04-19

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• 00840937113929: Quantisal® Oral Fluid Collection Device with Volume Adequacy Indicator
• 00840937113912: Quantisal® Oral Fluid Collection Device with Volume Adequacy Indicator
• 00840937114605: Negative Oral Fluid Calibrator 2
• 00840937114599: Ecstasy Oral Fluid Control Set
• 00840937114568: Ecstasy Oral Fluid Calibrator 2
• 00840937114544: SEFRIA™ Ecstasy Oral Fluid
• 00840937114537: SEFRIA™ Ecstasy Oral Fluid
• 00840937114674: Hydrocodone Oral Fluid Control Set
• 00840937114667: Hydrocodone Oral Fluid Calibrator 4
• 00840937114650: Hydrocodone Oral Fluid Calibrator 3
• 00840937114643: Hydrocodone Oral Fluid Calibrator 2
• 00840937114636: Hydrocodone Oral Fluid Calibrator 1
• 00840937114629: SEFRIA™ Hydrocodone Oral Fluid
• 00840937114612: SEFRIA™ Hydrocodone Oral Fluid