FDA UDI
In Commercial Distribution
🇺🇸 United States
ACE Reagent
DI: 08058056685339
·
Model: 06U8625
·
SENTINEL CH. SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACE Reagent
- Primary DI
- 08058056685339
- Version / Model
- 06U8625
- Catalog Number
- 06U8625
- Company Name
- SENTINEL CH. SPA
- Labeler DUNS
- 429572365
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-27
- Public Version
- 1
- Public Version Date
- 2025-02-04
- Public Version Status
- New
- Public Device Record Key
- cc5c0aa9-7ffe-49c1-ac80-3b1197072898
Device Description
The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin converting enzyme (ACE) activity in human serum or plasma on the Alinity c system. This test is used as an aid in the diagnosis of pulmonary sarcoidosis and other pathologic conditions involving lung and liver diseases. For laboratory professional use only.
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
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KQN | Radioassay, Angiotensin Converting Enzyme | Clinical Chemistry | 862.1090 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52945 | Angiotensin converting enzyme (ACE) 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 qualitative and/or quantitative detection of angiotensin converting enzyme (ACE) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08058056685339 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store between 2 and 8 degrees Celsius