FDA UDI
In Commercial Distribution
🇺🇸 United States
Alinity-Architect
DI: 00380740168209
·
Model: 01P0603
·
ABBOTT LABORATORIES
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Alinity-Architect
- Primary DI
- 00380740168209
- Version / Model
- 01P0603
- Catalog Number
- 01P0603
- Company Name
- ABBOTT LABORATORIES
- Labeler DUNS
- 079226220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2019-06-14
- Public Version
- 5
- Public Version Date
- 2025-07-28
- Public Version Status
- Update
- Public Device Record Key
- 63d10d7e-b9da-422a-a37b-11a0c80a5835
Device Description
Transplant Pretreatment Tubes
Device Characteristics
- Single Use
- Yes
- 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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MLM | ENZYME IMMUNOASSAY, TRACROLIMUS | Clinical Chemistry | 862.1678 | 2 |
| MKW | CYCLOSPORINE | Clinical Chemistry | 862.1235 | 2 |
| NRP | Sirolimus test system | Clinical Toxicology | 862.3840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62225 | Assay container IVD, single-use | A reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740168209 | GS1 | ||||
| Unit of Use | 00380740177874 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius