Neonatal Phenylalanine ELISA Kit (without membrane) 07575305

GUDID 00817830022344

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

MP BIOMEDICALS, LLC

Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, enzyme immunoassay (EIA) Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00817830022344
• NIH Device Record Key: eaa6a073-b25c-4b08-a130-7df708646782
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neonatal Phenylalanine ELISA Kit (without membrane)
• Version Model Number: 07575305
• Catalog Number: 07575305
• 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	00817830022344 [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.