Identity
- Trade Name
- cobas® BKV FDA UDI
- Generic Name
- BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 08688249190 FDA UDI
Identifiers
- Catalog Number
- 08688249190 FDA UDI
- Primary DI / UDI-DI
- 00875197006278 FDA UDI
- 510(k) Number
- K202215 FDA UDI
- FDA Product Code
- QLX FDA UDI
- GMDN Term
- BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3183 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: BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
cobas® BKV by Roche Molecular Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT).
- MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 100 — ELITECHGROUP INC. · Class I
- MGB Alert® BKV Probe Mix ASR-480rxn — ELITechGroup MDX LLC. · Class I
- MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-100 — ELITECHGROUP INC. · Class I
- MGB Alert® BKV Primer Mix ASR - 480 Reactions — ELITechGroup MDX LLC. · Class I
- MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-25 — ELITECHGROUP INC. · Class I
- MGB Alert BK Virus Primer Mix ASR, 09N38-003 — ELITechGroup MDX LLC. · Class I
- DSQ Alert BK Virus v3.0 Primer Mix — ELITechGroup MDX LLC. · Class I
- MGB Alert® BKV Probe Mix ASR-48rxn — ELITechGroup MDX LLC. · Class I
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
- Roche Molecular Systems, Inc.
Sources (1)
- FDA UDI 445265a5-05d1-4279-bbe0-cba62b7a8017 34 fields · synced Jun 9, 2026