Identity
- Trade Name
- CD39 [EPR20627] FDA UDI
- Generic Name
- Niemann-Pick disease (SMPD1-associated) IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- AVI3283G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627030580 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Niemann-Pick disease (SMPD1-associated) IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Niemann-Pick disease (SMPD1-associated) IVD, kit, nucleic acid technique (NAT)
Cd39 [epr20627] by Biocare Medical, Llc — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (1)
- FDA UDI ad8fffe2-d981-4b63-93eb-a103796ca8ec 33 fields · synced May 31, 2026