← Back to catalogue
NeoGram Derivatized Assay Solutions
FDA UDIClass II (US FDA UDI)
by Wallac, Inc.
Identity
- Trade Name
- NeoGram Derivatized Assay Solutions FDA UDI
- Generic Name
- Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 3030-0020 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 3030-0020 FDA UDI
- Primary DI / UDI-DI
- 06438147283842 FDA UDI
- 510(k) Number
- DEN040002 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
- Not 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
No
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
No
FDA UDI
NeoGram Derivatized Assay Solutions by Wallac, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wallac, Inc.
Sources (1)
- FDA UDI 942d8fcf-a3cc-431c-b8e1-ae801d719cc2 37 fields · synced Jun 8, 2026