FDA UDI
In Commercial Distribution
🇺🇸 United States
Alinity m
DI: 00884999049314
·
Model: 09N20-012
·
ABBOTT MOLECULAR INC.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alinity m
- Primary DI
- 00884999049314
- Version / Model
- 09N20-012
- Catalog Number
- 09N20-012
- Company Name
- ABBOTT MOLECULAR INC.
- Labeler DUNS
- 878263359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-18
- Public Version
- 1
- Public Version Date
- 2022-05-26
- Public Version Status
- New
- Public Device Record Key
- 990bfb2d-8e26-45dc-baa6-bb3a371daf56
Device Description
Alinity m Bottle for Ethanol Use
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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MKZ | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | Microbiology | 866.3120 | 1 |
| QEP | Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections | Microbiology | 866.3393 | 2 |
| OUY | Trichomonas vaginalis nucleic acid amplification test system | Immunology | 866.3860 | 2 |
| OOI | real time Nucleic acid amplification system | Clinical Chemistry | 862.2570 | 2 |
| LSL | DNA-REAGENTS, NEISSERIA | Microbiology | 866.3390 | 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 | 00884999049314 | GS1 |
Customer Contacts
- Phone
- +1(800)553-7042
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius