FDA UDI
In Commercial Distribution
🇺🇸 United States
Crosslaps Serum ELISA
DI: 00840239021243
·
Model: EIA-2124
·
DRG International Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Crosslaps Serum ELISA
- Primary DI
- 00840239021243
- Version / Model
- EIA-2124
- Catalog Number
- EIA-2124
- Company Name
- DRG International Inc
- Labeler DUNS
- 075150847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-23
- Public Version
- 1
- Public Version Date
- 2023-08-31
- Public Version Status
- New
- Public Device Record Key
- f2a4cff9-a233-4b05-a648-737b6ed6c093
Device Description
The Crosslaps Serum ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type I collagen in human serum and plasma.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47421 | Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of collagen type I cross-linked C-telopeptides in a clinical specimen, using an enzyme immunoassay (EIA) method. Collagen type I cross-linked C-telopeptide is a biomarker for bone turnover and elevated levels are associated with conditions of increased bone lysis (e.g., multiple myeloma, osteolytic metastases, and rheumatoid arthritis). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840239021243 | GS1 |
Customer Contacts
- Phone
- 9735647555
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111650 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius