FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroVue
DI: 30014613333906
·
Model: DPD EIA
·
QUIDEL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MicroVue
- Primary DI
- 30014613333906
- Version / Model
- DPD EIA
- Catalog Number
- 8007
- Company Name
- QUIDEL CORPORATION
- Labeler DUNS
- 079509836
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-30
- Public Version
- 2
- Public Version Date
- 2023-06-29
- Public Version Status
- Update
- Public Device Record Key
- e7161c1d-f141-4946-a2fc-778f9b152f24
Device Description
Kit, McVu DPD
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
- 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 |
|---|---|---|---|---|
| 53654 | Collagen pyridium crosslink IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the pyridium crosslinks of collagen, deoxypyridinoline (DPD) and/or pyridinoline (PYD), in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used as a specific marker of bone resorption and osteoclastic activity to help in the diagnosis of bone disease (e.g., postmenopausal osteoporosis, bone metastasis, and Paget's disease) or in monitoring collagen resorption changes in patients receiving antiresorptive therapy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30014613333906 | GS1 |
Customer Contacts
- Phone
- +1(858)552-1100
- [email protected]