Neonatal Phenylalanine ELISA Kit (without membrane) 07575300

GUDID 00817830022320

ELISA kit for the quantitative detection of phenylalanine in neonatal blood spots.

MP BIOMEDICALS, LLC

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• Primary Device ID: 00817830022320
• NIH Device Record Key: 69c55307-d78e-47b2-a627-a1208ce6d642
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neonatal Phenylalanine ELISA Kit (without membrane)
• Version Model Number: 07575300
• Catalog Number: 07575300
• Company DUNS: 137825928
• Company Name: MP BIOMEDICALS, LLC
• 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

Customer Support Contacts

• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com

Device Dimensions

• Length: 25.5 Centimeter
• Length: 25.5 Centimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817830022320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926106

FDA Product Code

• JNB: NINHYDRIN AND L-LEUCYL-L-ALANINE (FLUORIMETRIC), PHENYLALANINE

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: 2018-07-06
• Device Publish Date: 2016-10-20

On-Brand Devices [Neonatal Phenylalanine ELISA Kit (without membrane)]

• 00817830022344: ELISA kit for the quantitative detection of phenylalanine in neonatal blood spots.
• 00817830022320: ELISA kit for the quantitative detection of phenylalanine in neonatal blood spots.