Immunalysis NegOFLP-0100

GUDID 00840937114605

Negative Oral Fluid Calibrator 2

IMMUNALYSIS CORP

Multiple-type clinical chemistry analyte profile IVD, calibrator

• Primary Device ID: 00840937114605
• NIH Device Record Key: 5003e347-db11-4a90-bf3e-1dd7f8d894e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immunalysis
• Version Model Number: NegOFLP-0100
• Catalog Number: NegOFLP-0100
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840937114605 [Primary]

FDA Product Code

• DLJ: Calibrators, drug specific

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: 2024-04-16
• Device Publish Date: 2024-04-08

On-Brand Devices [Immunalysis]

• 00840937113936: Quantisal® Oral Fluid Collection Device with Volume Adequacy Indicator
• 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