| Primary Device ID | B24280PANHUFC1000 |
| NIH Device Record Key | 903fe5a6-8bc0-4762-98fb-c0d1eb83f398 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALPCO Pancreatic Elastase CLIA |
| Version Model Number | 80-PANHU-FC100 |
| Catalog Number | 80-PANHU-FC100 |
| 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 |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com |
| 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 |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | B24280PANHUFC1000 [Primary] |
| JNN | P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-02 |
| Device Publish Date | 2024-07-25 |
| B24211GLUHUE010 - Glucagon ELISA | 2024-10-31 The Glucagon ELISA is a quantitative Enzyme-Linked Immunosorbent Assay for the determination of Glucagon in human EDTA plasma sa |
| B24280PANHUFC1000 - ALPCO Pancreatic Elastase CLIA | 2024-08-02The Pancreatic Elastase CLIA kit is a chemiluminescent immunoassay (CLIA) intended for use by trained laboratory personnel for the quantitative measurement of fecal pancreatic elastase (PE) in human stool. The Pancreatic Elastase CLIA kit is intended for in vitro diagnostic use as an aid in the diagnosis and treatment of pancreatic disease, including exocrine pancreatic insufficiency (EPI), in conjunction with other clinical and laboratory findings. The test is specifically designed for use with the KleeYa platform. For In Vitro Diagnostic Use in the United States. |
| B24280PANHUFC1000 - ALPCO Pancreatic Elastase CLIA | 2024-08-02 The Pancreatic Elastase CLIA kit is a chemiluminescent immunoassay (CLIA) intended for use by trained laboratory personnel for t |
| B24220TT3HUE011 - Total Triiodothyronine (Total T3) ELISA | 2024-07-30 The Total Triiodothyronine (Total T3) ELISA Kit is intended for the quantitative determination of total triiodothyronine (T3) co |
| B24280CALPHUIT2000 - ALPCO Calprotectin Immunoturbidimetric Assay | 2023-08-28 The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of hu |
| B24280CALPHUITCAL0 - Calprotectin Immunoturbidimetric Assay - Calibrators | 2023-08-28 The Calprotectin Immunoturbidimetric Assay - Calibrators is an accessory used in conjunction with the Calprotectin Immunoturbidi |
| B24280CALPHUITCON0 - ALPCO Calprotectin Immunoturbidimetric Assay | 2023-08-28 The Calprotectin Immunoturbidimetric Assay - Controls is an accessory used in conjunction with the Calprotectin Immunoturbidimet |
| B24280CALPHUIT100 - ALPCO Calprotectin Immunoturbidimetric Assay | 2023-06-19 The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of hu |
| B24220EDLHUUE010 - Ultrasensitive Estradiol ELISA | 2023-06-15 The Ultrasensitive Estradiol ELISA is an enzyme immunoassay for the quantitative measurement of estradiol in serum or plasma (ED |