Identity
- Trade Name
- QBC Diagnostics FDA UDI
- Generic Name
- Biological stain kit IVD FDA UDI
- Device Name
- QBC F.A.S.T. AFB Detection System - ParaLens Advance with 20X & 40X Objectives and Centrifuge (115V) FDA UDI
- Model / Reference
- 427420 FDA UDI
- Description
- QBC F.A.S.T. AFB Detection System - ParaLens Advance with 20X & 40X Objectives and Centrifuge (115V) FDA UDI
Identifiers
- Catalog Number
- 427420 FDA UDI
- Primary DI / UDI-DI
- 00858092006215 FDA UDI
- FDA Product Code
- JSY FDA UDIGKB FDA UDI
- GMDN Term
- Biological stain kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 FDA UDI864.5800 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
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: Biological stain kit IVD
QBC Diagnostics by Drucker Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biological stain kit IVD.
- QBC Diagnostics — DRUCKER DIAGNOSTICS · Class I
- QBC Diagnostics — DRUCKER DIAGNOSTICS · Class II
- QBC Diagnostics — DRUCKER DIAGNOSTICS · Class II
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
- Drucker Diagnostics
Sources (1)
- FDA UDI 08bbc352-d7c9-4323-8f90-13838b2723aa 34 fields · synced Jun 6, 2026