FDA UDI
In Commercial Distribution
🇺🇸 United States
IMMULITE® Systems COR Calibration Verification Material Cortisol
DI: 00630414977485
·
Model: 10487396
·
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- IMMULITE® Systems COR Calibration Verification Material Cortisol
- Primary DI
- 00630414977485
- Version / Model
- 10487396
- Catalog Number
- LCOCVM
- Company Name
- SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Labeler DUNS
- 296822794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 2
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- 5bcafe41-037b-4884-8813-55f29a2d57f3
Device Description
Cortisol Sample Diluent CVM - IMMULITE - CONS
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
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LCP | ASSAY, GLYCOSYLATED HEMOGLOBIN | Hematology | 864.7470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54127 | Total cortisol 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 total cortisol in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414977485 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141444 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -70 – -20 Degrees Celsius