FDA UDI
In Commercial Distribution
🇺🇸 United States
Elecsys CrossLapsserum Immunoassay
DI: 04015630938902
·
Model: 11972308160
·
Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Elecsys CrossLapsserum Immunoassay
- Primary DI
- 04015630938902
- Version / Model
- 11972308160
- Catalog Number
- 11972308160
- Company Name
- Roche Diagnostics GmbH
- Labeler DUNS
- 315028860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 4
- Public Version Date
- 2021-12-08
- Public Version Status
- Update
- Public Device Record Key
- 927f83e4-e179-4d9a-8c68-ee9df590ec45
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JMM | COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE | Clinical Chemistry | 862.1400 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47420 | Collagen type I cross-linked C-telopeptide IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of collagen type I cross-linked C-telopeptides and/or metabolites [e.g., beta-isomerized C-terminal telopeptide of type I collagen (beta-CTx)] in a clinical specimen, using a chemiluminescent immunoassay method. Collagen type I cross-linked C-telopeptide and metabolites are typically used to aid in the diagnosis of conditions associated with elevated bone lysis/resorption (e.g., multiple myeloma, osteolytic metastasis, osteoporosis, rheumatoid arthritis). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04015630938902 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K993706 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius