Immunalysis Corporation

GUDID 00840937101681

Immunalysis Corporation Amphetamine Urine HEIA Kit 25

IMMUNALYSIS CORPORATION

Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840937101681
• NIH Device Record Key: 462c08e8-f0cc-419f-8417-def62cdc2c1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immunalysis Corporation
• Version Model Number: 309UR-0025
• Company DUNS: 080589004
• Company Name: IMMUNALYSIS CORPORATION
• 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

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
• 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
• 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
• 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
• 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	00840937101681 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143500

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

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: 2020-03-11
• Device Publish Date: 2016-08-31

On-Brand Devices [Immunalysis Corporation]

• 00840937111673: Immunalysis Corporation Meperidine Urine HEIA Kit 60 mL Wedge
• 00840937111666: Immunalysis Corporation Meperidine Urine HEIA Kit 500
• 00840937111659: Immunalysis Corporation Meperidine Urine HEIA Kit 100
• 00840937111642: Immunalysis Corporation Meperidine Urine HEIA Kit 25
• 00840937105825: Immunalysis Corporation Methylphenidate (Ritalin)
• 00840937104705: Immunalysis Corporation Methylphenidate (Ritalin) Positive Control (5 mL)
• 00840937104699: Immunalysis Corporation Methylphenidate (Ritalin) Positive Control (2 mL)
• 00840937108901: Immunalysis Corporation - Multi-Drug Calibrator Level 1 (25mL)
• 00840937108895: Immunalysis Corporation - Multi-Drug Calibrator Level 1 (15mL)
• 00840937108772: Immunalysis Corporation - Fentanyl Urine Control Set
• 00840937111833: Immunalysis Corporation - Quantisal Saliva Collection Devices - 500 Per Box
• 00840937111826: Immunalysis Corporation - Quantisal Saliva Collection Devices - 25 Per Box
• 00840937111819: Immunalysis Corporation - Tapentadol Urine Control Set
• 00840937111802: Immunalysis Corporation - Tapentadol Urine Calibrator - 1000 ng/mL
• 00840937111796: Immunalysis Corporation - Tapentadol Urine Calibrator - 300 ng/mL
• 00840937111789: Immunalysis Corporation - Tapentadol Urine Calibrator - 200 ng/mL
• 00840937111772: Immunalysis Corporation - Tapentadol Urine Calibrator - 100 ng/mL
• 00840937111765: Immunalysis Corporation - Tapentadol Urine HEIA Wedge Kit 60
• 00840937111758: Immunalysis Corporation - Tapentadol Urine HEIA Kit 500
• 00840937111741: Immunalysis Corporation - Tapentadol Urine HEIA Kit 100
• 00840937111734: Immunalysis Corporation - Tapentadol Urine HEIA Kit 25
• 00840937111635: Immunalysis Corporation Benzodiazepines Oral Fluid Export Kit 500
• 00840937111628: Immunalysis Corporation Benzodiazepines Oral Fluid Export Kit 100
• 00840937111611: Immunalysis Corporation Benzodiazepines Oral Fluid Export Kit 25
• 00840937111604: Immunalysis Corporation Negative Reference Calibrator
• 00840937111598: Immunalysis Corporation Tramadol Urine HEIA Kit 25
• 00840937111581: Immunalysis Corporation Tramadol Urine Control Set
• 00840937111574: Immunalysis Corporation Tramadol Urine Calibrator Set
• 00840937111567: Immunalysis Corporation Tramadol Urine Calibrator
• 00840937111550: Immunalysis Corporation Oxycodone Urine HEIA 25
• 00840937111543: Immunalysis Corporation Oxycodone Urine Control Set 300
• 00840937111536: Immunalysis Corporation Oxycodone Urine Control Set 100
• 00840937111529: Immunalysis Corporation Oxycodone Urine Calibrator Set
• 00840937111512: Immunalysis Corporation Oxycodone Urine Calibrator 300
• 00840937111505: Immunalysis Corporation Oxycodone Urine Calibrator 100
• 00840937111499: Immunalysis Corporation Negative Calibrator
• 00840937111482: Immunalysis Corporation SEFRIA Fentanyl Urine Kit 25
• 00840937111475: Immunalysis Corporation Fentanyl Urine Control Set
• 00840937111468: Immunalysis Corporation Fentanyl Urine Calibrator Level 1 - 1 ng/mL
• 00840937111451: Immunalysis Corporation EDDP Specific Urine HEIA 25 Kit
• 00840937111444: Immunalysis Corporation EDDP Specific Urine Control Set Level 2
• 00840937111437: Immunalysis Corporation EDDP Specific Urine Control Set Level 1
• 00840937111420: Immunalysis Corporation EDDP Specific Urine Calibrator Level 4 - 1000 ng/mL
• 00840937111413: Immunalysis Corporation EDDP Specific Urine Calibrator Level 3 - 500 ng/mL
• 00840937111406: Immunalysis Corporation EDDP Specific Urine Calibrator Level 2 - 300 ng/mL
• 00840937111390: Immunalysis Corporation EDDP Specific Urine Calibrator Level 1 - 100 ng/ml
• 00840937111383: Immunalysis Corporation Buprenorphine Urine HEIA Kit 25
• 00840937111376: Immunalysis Corporation Buprenorphine Urine Control Set
• 00840937111369: Immunalysis Corporation Buprenorphine Urine Calibrator Set
• 00840937111352: Immunalysis Corporation Buprenorphine Urine Calibrator