FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoLSD MSMS kit
DI: 06438147411672
·
Model: 3093-004U
·
Wallac Oy
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NeoLSD MSMS kit
- Primary DI
- 06438147411672
- Version / Model
- 3093-004U
- Catalog Number
- 3093-004U
- Company Name
- Wallac Oy
- Labeler DUNS
- 540156544
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-15
- Public Version
- 1
- Public Version Date
- 2025-08-25
- Public Version Status
- New
- Public Device Record Key
- 7ded28ac-8aab-4ebd-92be-2893ad4c4e87
Device Description
For the quantitative measurement of the activity of certain lysosomal enzymes in dried blood spots. Note: Kit contains multiple packages.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| PQT | Alpha-L-Iduronidase (Idua) Newborn Screening Test System | Clinical Chemistry | 862.1488 | 2 |
| PQU | Alpha-D-Glucosidase (Gaa) Newborn Screening Test System | Clinical Chemistry | 862.1488 | 2 |
| PQV | ß-Glucocerebrosidase (Gba) Newborn Screening Test System | Clinical Chemistry | 862.1488 | 2 |
| PQW | Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | Clinical Chemistry | 862.1488 | 2 |
| QCL | Acid-Sphingomyelinase (Asm) Newborn Screening Test System | Clinical Chemistry | 862.1488 | 2 |
| QCM | ß-Galactocerebrosidase (Galc) Newborn Screening Test System | Clinical Chemistry | 862.1488 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60444 | Newborn metabolic screen/congenital disorder IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening of a clinical specimen for one or more congenital or metabolic disorders of the newborn, using a spectrophotometry method. It typically utilizes whole-blood neonate specimens dried on filter paper, and the analytes detected may include neonatal thyroxine (neonatal T4), neonatal thyroid stimulating hormone (neonatal TSH), 17-hydroxyprogesterone, immunoreactive trypsinogen, and various enzymes and/or amino acids, as indicators of congenital hypothyroidism, adrenal hyperplasia, cystic fibrosis, lysosomal storage disorders (LSDs), or other metabolic disorders. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438147411672 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173829 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -16 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius