Identity
- Trade Name
- VeriQuick FDA UDI
- Generic Name
- BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Pregnancy Test FDA UDI
- Model / Reference
- 11012450B FDA UDI
- Description
- Pregnancy Test FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00049696719018 FDA UDI
- FDA Product Code
- LCX 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
- 862.1155 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
No
FDA UDI
Category: BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
VeriQuick by Fourstar Group 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).
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- 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
- cobas® BKV — Roche Molecular Systems, Inc. · Class II
- 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
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
- Fourstar Group Inc.
Sources (1)
- FDA UDI ebd6975a-1b7e-48a0-889b-0605a3ceca6b 33 fields · synced May 30, 2026