FDA UDI
In Commercial Distribution
🇺🇸 United States
Pancreatic Elastase CLIA Re-Calibrator and Control Set
DI: B24280PANHUFCSET0
·
Model: 80-PANHU-FCSET
·
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Pancreatic Elastase CLIA Re-Calibrator and Control Set
- Primary DI
- B24280PANHUFCSET0
- Version / Model
- 80-PANHU-FCSET
- Company Name
- AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
- Labeler DUNS
- 784143778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-06
- Public Version
- 1
- Public Version Date
- 2025-06-16
- Public Version Status
- New
- Public Device Record Key
- 14ad916c-21ed-4e22-ad9b-1755423d7f95
Device Description
The 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JNN | P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | Clinical Chemistry | 862.1725 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53143 | Pancreatic elastase (PE) IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of pancreatic elastase (PE) in a clinical specimen. | No | Active |
| 53144 | Pancreatic elastase (PE) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of pancreatic elastase (PE) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B24280PANHUFCSET0 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius