Identity
- Trade Name
- MP Biomedicals LLC FDA UDI
- Generic Name
- Galactose IVD, kit, enzyme fluorescence FDA UDI
- Device Name
- NEONATAL GALACTOSE MW 10 PLATE ENZYME ASSAY KIT (WITHOUT MEMBRANE) FDA UDI
- Model / Reference
- 07553305 FDA UDI
- Description
- NEONATAL GALACTOSE MW 10 PLATE ENZYME ASSAY KIT (WITHOUT MEMBRANE) FDA UDI
Identifiers
- Catalog Number
- 07553305 FDA UDI
- Primary DI / UDI-DI
- 00817830023112 FDA UDI
- 510(k) Number
- K951329 FDA UDI
- FDA Product Code
- JIA FDA UDI
- GMDN Term
- Galactose IVD, kit, enzyme fluorescence FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Galactose IVD, kit, enzyme fluorescence
MP Biomedicals LLC by Mp Biomedicals, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Galactose IVD, kit, enzyme fluorescence.
- MP Biomedicals LLC — MP BIOMEDICALS, LLC · Class I
- MP Biomedicals LLC — MP BIOMEDICALS, LLC · Class I
- MP Biomedicals LLC — MP BIOMEDICALS, LLC · Class I
Cleared under the same submission
K951329 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Mp Biomedicals, Llc
Sources (1)
- FDA UDI 11a01054-31ed-479a-9fc5-8b049bb8a235 35 fields · synced Jun 8, 2026