Identity
- Trade Name
- Neonatal Biotinidase kit FDA UDI
- Generic Name
- Biotinidase IVD, kit, enzyme fluorescence FDA UDI
- Device Name
- For the semi-quantitative determination of biotinidase in dried blood. Note: Kit contains multiple packages. FDA UDI
- Model / Reference
- 3018-0010 FDA UDI
- Description
- For the semi-quantitative determination of biotinidase in dried blood. Note: Kit contains multiple packages. FDA UDI
Identifiers
- Catalog Number
- 3018-0010 FDA UDI
- Primary DI / UDI-DI
- 06438147291342 FDA UDI
- 510(k) Number
- K090123 FDA UDI
- FDA Product Code
- NAK FDA UDI
- GMDN Term
- Biotinidase IVD, kit, enzyme fluorescence FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1118 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
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
Category: Biotinidase IVD, kit, enzyme fluorescence
Neonatal Biotinidase kit by Wallac, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biotinidase IVD, kit, enzyme fluorescence.
- GSP Neonatal Biotinidase 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 870401a6-f292-4fb6-ae19-c11fc2eeaa7e 36 fields · synced May 30, 2026