Identity
- Trade Name
- MGB Alert® BKV Probe Mix ASR-48rxn FDA UDI
- Generic Name
- BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- "MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6- carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm." FDA UDI
- Model / Reference
- 800421 FDA UDI
- Description
- "MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6- carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm." FDA UDI
Identifiers
- Catalog Number
- 800421 FDA UDI
- Primary DI / UDI-DI
- 03661540951534 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
Yes
FDA UDI
Category: BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® BKV Probe Mix ASR-48rxn by ELITechGroup MDX LLC. — Class I — 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 - 480 Reactions QTY-100 — ELITECHGROUP INC. · Class I
- MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-25 — ELITECHGROUP INC. · Class I
- cobas® BKV — Roche Molecular Systems, Inc. · Class II
- Alinity m — Abbott Molecular · Class II
- VeriQuick — FOURSTAR GROUP INC. · Class II
- MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 25 — ELITECHGROUP INC. · Class I
- MGB Alert® BKV Probe Mix ASR-480rxn — 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 I | Pending data |
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Manufacturer
- Manufacturer
- ELITechGroup MDX LLC.
Sources (1)
- FDA UDI c3f00b7c-1c4b-4582-9d22-bd0b275597ac 36 fields · synced May 30, 2026