Immunalysis Corporation 647OF-0100

GUDID 00840937111864

SEFRIA 6-Acetylmorphine Oral Fluid Enzyme Immunoassay 100mL Kit

IMMUNALYSIS CORPORATION

6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840937111864
• NIH Device Record Key: ce55e60e-549b-448b-b99b-76789738d0c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immunalysis Corporation
• Version Model Number: 647OF-0100
• Catalog Number: 647OF-0100
• Company DUNS: 080589004
• Company Name: IMMUNALYSIS CORPORATION
• 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

Customer Support Contacts

• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com
• Phone: +19094820840
• Email: info@immunalysis.com

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
• 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	00840937111864 [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: 2023-11-02
• Device Publish Date: 2023-10-25

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• 00840937111819: Immunalysis Corporation - Tapentadol Urine Control Set
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• 00840937111796: Immunalysis Corporation - Tapentadol Urine Calibrator - 300 ng/mL
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• 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
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• 00840937111598: Immunalysis Corporation Tramadol Urine HEIA Kit 25
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• 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
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• 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
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• 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
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