FDA UDI
In Commercial Distribution
🇺🇸 United States
Diazyme
DI: 00817089021822
·
Model: DZ170A-DZL
·
DIAZYME LABORATORIES, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diazyme
- Primary DI
- 00817089021822
- Version / Model
- DZ170A-DZL
- Company Name
- DIAZYME LABORATORIES, INC.
- Labeler DUNS
- 080507219
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-16
- Public Version
- 1
- Public Version Date
- 2020-07-24
- Public Version Status
- New
- Public Device Record Key
- e82bfb58-47cc-4115-9662-79f8df092f87
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53799 | Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of kappa and/or lambda light chain immunoglobulins in a clinical specimen, using a nephelometry/turbidimetry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817089021822 | GS1 |