PTH (Intact, 1-84) ELISA 21-IPTHU-E01

GUDID B24221IPTHUE010

The PTH (Intact, 1-84) ELISA is intended for use in the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum.

AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B24221IPTHUE010
• NIH Device Record Key: bd67b47c-a3e1-4140-a7cf-b172ed6f7a46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PTH (Intact, 1-84) ELISA
• Version Model Number: 21-IPTHU-E01
• Catalog Number: 21-IPTHU-E01
• Company DUNS: 784143778
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• 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: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B24221IPTHUE010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974306

FDA Product Code

• CEW: Radioimmunoassay, Parathyroid Hormone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2017-08-03

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