FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NeoGram Derivatized Assay Solutions
DI: 06438147283842
·
Model: 3030-0020
·
Wallac Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeoGram Derivatized Assay Solutions
- Primary DI
- 06438147283842
- Version / Model
- 3030-0020
- Catalog Number
- 3030-0020
- Company Name
- Wallac Oy
- Labeler DUNS
- 540156544
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-11
- Public Version
- 4
- Public Version Date
- 2022-03-30
- Public Version Status
- Update
- Public Device Record Key
- 942d8fcf-a3cc-431c-b8e1-ae801d719cc2
- Distribution End Date
- 2022-03-18
Device Description
The product is to be used together with the NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry kit, and is intended for the measurement of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper.
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 | 06438147283842 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN040002 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius