| Primary Device ID | B24280PANHUFCSET0 |
| NIH Device Record Key | 14ad916c-21ed-4e22-ad9b-1755423d7f95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pancreatic Elastase CLIA Re-Calibrator and Control Set |
| Version Model Number | 80-PANHU-FCSET |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 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 | B24280PANHUFCSET0 [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 | 2025-06-16 |
| Device Publish Date | 2025-06-06 |
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| B24280PANHUFCSET0 - Pancreatic Elastase CLIA Re-Calibrator and Control Set | 2025-06-16The Pancreatic Elastase CLIA Re-Calibrator and Control Set is an accessory used in conjunction with the Pancreatic Elastase CLIA kit (80-PANHU-FC100 or 80-PANHU-FC900) by trained laboratory personnel. For in vitro diagnostic use in the United States. |
| B24280PANHUFCSET0 - Pancreatic Elastase CLIA Re-Calibrator and Control Set | 2025-06-16 The Pancreatic Elastase CLIA Re-Calibrator and Control Set is an accessory used in conjunction with the Pancreatic Elastase CLIA |
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