FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoBase Succinylacetone Assay Solution
DI: 06438147295708
·
Model: 3042-0020
·
Wallac Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeoBase Succinylacetone Assay Solution
- Primary DI
- 06438147295708
- Version / Model
- 3042-0020
- Catalog Number
- 3042-0020
- Company Name
- Wallac Oy
- Labeler DUNS
- 540156544
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-11
- Public Version
- 5
- Public Version Date
- 2018-12-13
- Public Version Status
- Update
- Public Device Record Key
- 312a0807-2d2d-4315-8b69-c7f534ac573d
Device Description
The NeoBase™ Succinylacetone Assay Solution is intended for in vitro diagnostic use with the NeoBase Non-derivatized MSMS Kit and the NeoBase non-derivatized Assay Solutions. The NeoBase™ Succinylacetone Assay Solution is used for the measurement and evaluation of succinylacetone concentration from blood samples dried on filter paper (DBS).
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| NQL | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry | Clinical Chemistry | 862.1055 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58190 | Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple amino acids, nucleosides, lysophospholipids, and/or carnitine metabolites associated with metabolic disorders of a newborn in a clinical specimen, using a mass spectrometry method. Analytes detected may include all amino acids, free carnitine, acylcarnitine, succinylacetone, adenosine and/or lysophosphatidylcholine. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438147295708 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius