FDA UDI
In Commercial Distribution
🇺🇸 United States
Lipid Calibrator S
DI: 04987503563002
·
Model: 563002
·
DENKA COMPANY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Lipid Calibrator S
- Primary DI
- 04987503563002
- Version / Model
- 563002
- Company Name
- DENKA COMPANY LIMITED
- Labeler DUNS
- 694830238
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-29
- Public Version
- 3
- Public Version Date
- 2020-05-25
- Public Version Status
- Update
- Public Device Record Key
- 75a87d4f-816d-480d-8082-b2288f950a48
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41728 | Low density lipoprotein (LDL) cholesterol IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987503563002 | GS1 |
Customer Contacts
- Phone
- +1 408-371-8819
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- shading
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius