FDA UDI
In Commercial Distribution
🇺🇸 United States
Alpha CrossLaps® (CTX-I) EIA
DI: 05060169690165
·
Model: AC-04F1
·
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Alpha CrossLaps® (CTX-I) EIA
- Primary DI
- 05060169690165
- Version / Model
- AC-04F1
- Company Name
- IMMUNODIAGNOSTIC SYSTEMS LIMITED
- Labeler DUNS
- 494268600
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-01
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 27d7ee0d-beac-446c-99f2-1e005ca33946
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
- 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 |
|---|---|---|---|---|
| JMM | Column Chromatography & Color Development, Hydroxyproline | Clinical Chemistry | 862.1400 | 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 | 05060169690165 | GS1 |
Customer Contacts
- Phone
- +4401915190660
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store upon receipt at 2 to 8 degrees celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius