FDA UDI
In Commercial Distribution
🇺🇸 United States
Alinity m
DI: 00884999050594
·
Model: 09N61-095
·
ABBOTT MOLECULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Alinity m
- Primary DI
- 00884999050594
- Version / Model
- 09N61-095
- Catalog Number
- 09N61-095
- Company Name
- ABBOTT MOLECULAR INC.
- Labeler DUNS
- 878263359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-27
- Public Version
- 1
- Public Version Date
- 2024-08-05
- Public Version Status
- New
- Public Device Record Key
- 1b141f61-3f91-4e6c-8870-9cdeb4b3d7ec
Device Description
Alinity m HSV 1 & 2 / VZV 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 |
|---|---|---|---|---|
| PGI | Herpes virus (VZV, HSV1, HSV2), DNA detection assay for cutaneous and mucocutaneous lesion samples | Microbiology | 866.3309 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61334 | Multiple Human herpesvirus 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 one or multiple human herpesviruses in a clinical specimen, using a nucleic acid technique (NAT). Viruses detected may include (but not limited to) herpes simplex virus 1 (HSV1), herpes simplex virus 2 (HSV2) and/or varicella-zoster virus (VZV). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884999050594 | GS1 |
Customer Contacts
- Phone
- +1(800)553-7042
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233349 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -15 Degrees Celsius