Identity
- Trade Name
- STRATIFY JCV™ DXSELECT™ FDA UDI
- Generic Name
- JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- EL1950-5 FDA UDI
Identifiers
- Catalog Number
- EL1950-5 FDA UDI
- Primary DI / UDI-DI
- 20816101022261 FDA UDI
- 510(k) Number
- K120986 FDA UDI
- FDA Product Code
- OYP FDA UDI
- GMDN Term
- JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3336 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
No
FDA UDI
Category: JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA)
Stratify Jcv™ Dxselect™ by DiaSorin Molecular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA).
- IMMUNOWELL JCV IgG Test — Genbio · Class II
- STRATIFY JCV™ DXSELECT™ — DiaSorin Molecular LLC · Class II
Cleared under the same submission
K120986 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 II | Pending data |
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Manufacturer
- Manufacturer
- DiaSorin Molecular LLC
Sources (1)
- FDA UDI 007ed3c0-a9b2-4200-bdcb-120f5e64a1dd 36 fields · synced Jun 9, 2026