FDA UDI
In Commercial Distribution
🇺🇸 United States
ADS/APS CONTROL SOLUTION V3
DI: B800ADSAPSV3CONTFCCO0
·
Model: ADS/APSV3CONTFCCO
·
UTAK LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ADS/APS CONTROL SOLUTION V3
- Primary DI
- B800ADSAPSV3CONTFCCO0
- Version / Model
- ADS/APSV3CONTFCCO
- Catalog Number
- ADS/APSV3CONTFCCO
- Company Name
- UTAK LABORATORIES, INC.
- Labeler DUNS
- 092519016
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-18
- Public Version
- 1
- Public Version Date
- 2023-05-26
- Public Version Status
- New
- Public Device Record Key
- 9737ab59-acd7-4628-991d-f3554ce3d3b6
Device Description
ADS/APS CONTROL SOLUTION V3
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| LAS | Drug Specific Control Materials | Clinical Toxicology | 862.3280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55235 | Multiple-therapy therapeutic drug monitoring IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B800ADSAPSV3CONTFCCO5 | HIBCC | box | 2 | In Commercial Distribution | |
| Primary | B800ADSAPSV3CONTFCCO0 | HIBCC |
Customer Contacts
- Phone
- 1-888-882-5522
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 25 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -10 Degrees Celsius