FDA UDI
In Commercial Distribution
🇺🇸 United States
Urine Calibration Standard
DI: 04250317544797
·
Model: 53003
·
Chromsystems Instruments + Chemicals GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Urine Calibration Standard
- Primary DI
- 04250317544797
- Version / Model
- 53003
- Catalog Number
- 53003
- Company Name
- Chromsystems Instruments + Chemicals GmbH
- Labeler DUNS
- 328712260
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-23
- Public Version
- 1
- Public Version Date
- 2019-05-01
- Public Version Status
- New
- Public Device Record Key
- 882f9f8a-1eba-487a-9930-49d6c876339c
Device Description
Urine Calibration Standard 1-Hydroxypyrene
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JIT | Calibrator, Secondary | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64201 | Polycyclic aromatic hydrocarbon (PAH) metabolite 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 one or multiple metabolites/biomarkers associated with occupational or environmental exposure to polycyclic aromatic hydrocarbons (PAH) [e.g., derived from fossil fuels combustion, or tobacco smoke] in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04250317538536 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 04250317544797 | GS1 |
Customer Contacts
- Phone
- +4989189300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5 x 5ml |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius