| Primary Device ID | B24230PANHUE010 |
| NIH Device Record Key | 02d39031-2e6a-4cb8-b65e-116759618c5e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pancreatic Elastase ELISA |
| Version Model Number | 30-PANHU-E01 |
| Catalog Number | 30-PANHU-E01 |
| 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 |
| 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 | B24230PANHUE010 [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 | 2020-07-27 |
| Device Publish Date | 2020-07-17 |
| 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 |
| B24211PRNHUE010 - Pregnenolone ELISA | 2023-06-02 Intended for the direct quantitative determination of Pregnenolone by enzyme immunoassay using human serum. For in vitro diagnos |
| B24211FTEHUE010 - Free Testosterone ELISA | 2023-05-03 For the direct quantitative determination of Free Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic |
| B24220PROHUE010 - Prolactin ELISA | 2023-03-02 The Prolactin ELISA is an enzyme immunoassay for the quantitative determination of Prolactin in human serum. For in vitro diagno |