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NeoBase 2 Non-derivatized MSMS kit
FDA UDIClass II (US FDA UDI)
by Wallac, Inc.
Identity
- Trade Name
- NeoBase 2 Non-derivatized MSMS kit FDA UDI
- Generic Name
- Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry FDA UDI
- Device Name
- NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations from newborn heel prick blood samples dried on filter paper. FDA UDI
- Model / Reference
- 3044-001U FDA UDI
- Description
- NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations from newborn heel prick blood samples dried on filter paper. FDA UDI
Identifiers
- Catalog Number
- 3044-001U FDA UDI
- Primary DI / UDI-DI
- 06438147356812 FDA UDI
- FDA Product Code
- NQL FDA UDI
- GMDN Term
- Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1055 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry
NeoBase 2 Non-derivatized MSMS kit by Wallac, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry.
- NeoBase Non-derivatized MSMS kit — Wallac, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Wallac, Inc.
Sources (1)
- FDA UDI 1e153d8c-6880-4479-b1ca-c7d46850bf60 36 fields · synced Jun 8, 2026