FDA UDI
In Commercial Distribution
🇺🇸 United States
Diazyme
DI: 00817089023222
·
Model: 100148B-CAL
·
DIAZYME LABORATORIES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diazyme
- Primary DI
- 00817089023222
- Version / Model
- 100148B-CAL
- Company Name
- DIAZYME LABORATORIES, INC.
- Labeler DUNS
- 080507219
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-21
- Public Version
- 1
- Public Version Date
- 2026-01-29
- Public Version Status
- New
- Public Device Record Key
- ef0094ea-b1db-4897-9b8e-33313e9e2881
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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JIT | Calibrator, Secondary | Clinical Chemistry | 862.1150 | 2 |
| NOE | Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 | Immunology | 866.5600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53156 | Phospholipase A2 IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of the enzyme phospholipase A2 in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817089023222 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141575 | 000 |