Pancreatic Elastase Chemiluminescence ELISA 80-PANHU-CH01

GUDID B24280PANHUCH010

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.

Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA)
Primary Device IDB24280PANHUCH010
NIH Device Record Key3c852f3b-532d-4d14-ab69-e3f230221673
Commercial Distribution StatusIn Commercial Distribution
Brand NamePancreatic Elastase Chemiluminescence ELISA
Version Model Number80-PANHU-CH01
Catalog Number80-PANHU-CH01
Company DUNS784143778
Company NameAMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB24280PANHUCH010 [Primary]

FDA Product Code

JNNP-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-19
Device Publish Date2022-09-09

On-Brand Devices [Pancreatic Elastase Chemiluminescence ELISA]

B24280PANHUCH500The Pancreatic Elastase Chemiluminescence ELISA is a quantitative assay for the determination of
B24280PANHUCH010The Pancreatic Elastase Chemiluminescence ELISA is a quantitative assay for the determination of
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.