Pancreatic Elastase Chemiluminescence ELISA 80-PANHU-CH50

GUDID B24280PANHUCH500

The Pancreatic Elastase Chemiluminescence ELISA is a quantitative assay for the determination of pancreatic elastase (PE) in human stool. This assay detects both the CELA3A and CELA3B isoforms of pancreatic elastase.

AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

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• Primary Device ID: B24280PANHUCH500
• NIH Device Record Key: 4d93516f-1907-4d28-bd6e-31ba27bef871
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pancreatic Elastase Chemiluminescence ELISA
• Version Model Number: 80-PANHU-CH50
• Catalog Number: 80-PANHU-CH50
• Company DUNS: 784143778
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• 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: 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
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• 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
• 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
HIBCC	B24280PANHUCH500 [Primary]

FDA Product Code

• JNN: P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin

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: 2022-09-19
• Device Publish Date: 2022-09-09

On-Brand Devices [Pancreatic Elastase Chemiluminescence ELISA]

• B24280PANHUCH500: The Pancreatic Elastase Chemiluminescence ELISA is a quantitative assay for the determination of
• B24280PANHUCH010: The Pancreatic Elastase Chemiluminescence ELISA is a quantitative assay for the determination of