FDA UDI
In Commercial Distribution
🇺🇸 United States
BÜHLMANN fCAL® turbo Reagent Kit
DI: EBUHBKCALRSETUS0
·
Model: B-KCAL-RSET-US
·
Bühlmann Laboratories AG
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BÜHLMANN fCAL® turbo Reagent Kit
- Primary DI
- EBUHBKCALRSETUS0
- Version / Model
- B-KCAL-RSET-US
- Company Name
- Bühlmann Laboratories AG
- Labeler DUNS
- 481261006
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-02
- Public Version
- 1
- Public Version Date
- 2023-05-10
- Public Version Status
- New
- Public Device Record Key
- 8f6006ee-b580-4de3-99cf-236ed255b757
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53627 | Calprotectin IVD, reagent | A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of calprotectin protein in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EBUHBKCALRSETUS0 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius