FDA UDI
In Commercial Distribution
🇺🇸 United States
Alinity m
DI: 00884999047686
·
Model: 09N18-001
·
ABBOTT MOLECULAR INC.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alinity m
- Primary DI
- 00884999047686
- Version / Model
- 09N18-001
- Catalog Number
- 09N18-001
- 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
- af03bc44-1519-48d9-a0a2-8ac81962774d
Device Description
Alinity m Sample Prep Kit 1
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 |
|---|---|---|---|---|
| QEP | Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections | Microbiology | 866.3393 | 2 |
| MKZ | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | Microbiology | 866.3120 | 1 |
| LSL | DNA-REAGENTS, NEISSERIA | Microbiology | 866.3390 | 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52521 | Nucleic acid extraction/isolation kit IVD | A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884999047686 | GS1 |
Customer Contacts
- Phone
- +1(800)553-7042
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius