FDA UDI
In Commercial Distribution
🇺🇸 United States
AutoUA®
DI: 00854080008643
·
Model: 217-S
·
Sciteck Diagnostics, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AutoUA®
- Primary DI
- 00854080008643
- Version / Model
- 217-S
- Catalog Number
- 217-S
- Company Name
- Sciteck Diagnostics, Inc.
- Labeler DUNS
- 041137964
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-07
- Public Version
- 1
- Public Version Date
- 2026-04-15
- Public Version Status
- New
- Public Device Record Key
- d040514d-103b-49fa-b29d-19f76ee5bb4a
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| 60774 | Carbon dioxide (CO2) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of bicarbonate (HCO3-) ions [as a measure of carbon dioxide (CO2) concentration] in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854080008643 | GS1 |
Customer Contacts
- Phone
- 800-749-4537
- [email protected]