FDA UDI
In Commercial Distribution
🇺🇸 United States
Alinity m
DI: 00884999049505
·
Model: 09N43-095
·
ABBOTT MOLECULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alinity m
- Primary DI
- 00884999049505
- Version / Model
- 09N43-095
- Catalog Number
- 09N43-095
- Company Name
- ABBOTT MOLECULAR INC.
- Labeler DUNS
- 878263359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-29
- Public Version
- 1
- Public Version Date
- 2022-09-06
- Public Version Status
- New
- Public Device Record Key
- e84c2a3b-a9f8-43b4-acf5-a5dcc47d2831
Device Description
Alinity m EBV AMP Kit
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QLX | Nucleic acid amplification test for the quantitation of epstein-barr virus (EBV) DNA | Microbiology | 866.3183 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49653 | Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Epstein-Barr virus (EBV) in a clinical specimen, using a nucleic acid technique (NAT). The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884999049505 | GS1 |
Customer Contacts
- Phone
- +1(800) 553-7042
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212778 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius