FDA UDI
In Commercial Distribution
🇺🇸 United States
Adenosine Deaminase Assay Kit
DI: 00817089020825
·
Model: DZ117A-K
·
DIAZYME LABORATORIES, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Adenosine Deaminase Assay Kit
- Primary DI
- 00817089020825
- Version / Model
- DZ117A-K
- Company Name
- DIAZYME LABORATORIES, INC.
- Labeler DUNS
- 080507219
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-26
- Public Version
- 1
- Public Version Date
- 2023-11-03
- Public Version Status
- New
- Public Device Record Key
- f622db21-91ad-4dcf-a38d-7dfa970d109f
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52921 | Adenosine deaminase (ADA) IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of adenosine deaminase (ADA) in a clinical specimen, using a spectrophotometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817089020825 | GS1 |