Immunalysis Corporation

GUDID 00840937106624

Immunalysis Corporation Methylphenidate Conjugate (15 mL)

ALERE INC.

Multiple catecholamine IVD, reagent

• Primary Device ID: 00840937106624
• NIH Device Record Key: 586e8844-f6da-49bd-8852-02930b8fdacb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immunalysis Corporation
• Version Model Number: FC-219-15
• Company DUNS: 093803398
• Company Name: ALERE 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840937106624 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-31

On-Brand Devices [Immunalysis Corporation]

• 00840937106648: Immunalysis Corporation Methylphenidate Conjugate (750 mL)
• 00840937106631: Immunalysis Corporation Methylphenidate Conjugate (60 mL)
• 00840937106624: Immunalysis Corporation Methylphenidate Conjugate (15 mL)
• 00840937105443: Immunalysis Corporation Methylphenidate Conjugate
• 00840937100394: Immunalysis Corporation Methylphenidate Direct ELISA Kit (Ritalin): 50 plate
• 00840937100387: Immunalysis Corporation Methylphenidate Direct ELISA Kit (Ritalin): 5 plate
• 00840937100370: Immunalysis Corporation Methylphenidate Direct ELISA Kit (Ritalin): 1 plate