FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoBase 2 Non-derivatized Assay Solutions
DI: 06438147348107
·
Model: 3045-0010
·
Wallac Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeoBase 2 Non-derivatized Assay Solutions
- Primary DI
- 06438147348107
- Version / Model
- 3045-0010
- Catalog Number
- 3045-0010
- Company Name
- Wallac Oy
- Labeler DUNS
- 540156544
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-25
- Public Version
- 2
- Public Version Date
- 2020-04-30
- Public Version Status
- Update
- Public Device Record Key
- 35dab8d3-b71d-41be-998f-d87a26fead89
Device Description
NeoBase™ 2 Non-derivatized Assay Solutions are intended for in vitro diagnostic use with the NeoBase 2 Non-derivatized MSMS kit to extract target analytes from blood samples dried on filter paper and to carry target analytes to the MSMS system.
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 |
|---|---|---|---|---|
| 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 | 06438147348107 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173568 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in the dark
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from heat and sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius