FDA UDI
In Commercial Distribution
🇺🇸 United States
Alinity mp
DI: 00884999048959
·
Model: 09N65-005
·
ABBOTT MOLECULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Alinity mp
- Primary DI
- 00884999048959
- Version / Model
- 09N65-005
- Catalog Number
- 09N65-005
- Company Name
- ABBOTT MOLECULAR INC.
- Labeler DUNS
- 878263359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-25
- Public Version
- 1
- Public Version Date
- 2024-05-03
- Public Version Status
- New
- Public Device Record Key
- 47d76484-da34-432f-872b-c3f695cc78c9
Device Description
Alinity mp SurePath Holder, Replacement
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JQW | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE | Clinical Chemistry | 862.2750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62011 | Instrument/analyser specimen/reagent container carrier IVD | A device intended to hold a specimen/reagent container (e.g., test tube, tissue specimen petri dish, microplate, cuvette) on board an in vitro diagnostic laboratory instrument or analyser (e.g., PCR machine, spectrophotometric plate reader, biopsy specimen analyser, automated liquid handling station). It may be in the form of a removable tray (excludes immunoassay vehicle trays), holder, shuttle, rack/rack base, slotted case, or other format suitable to be handled and loaded into the parent device by the operator or via an automated process. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884999048959 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius