Identity
- Trade Name
- QBC Diagnostics FDA UDI
- Generic Name
- Capillary blood collection tube IVD, no additive FDA UDI
- Device Name
- Malaria Tube - Blood Collection Device (2000 Test Kit) FDA UDI
- Model / Reference
- 253005 FDA UDI
- Description
- Malaria Tube - Blood Collection Device (2000 Test Kit) FDA UDI
Identifiers
- Catalog Number
- 253005 FDA UDI
- Primary DI / UDI-DI
- 00858092006475 FDA UDI
- 510(k) Number
- K891276 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- GMDN Term
- Capillary blood collection tube IVD, no additive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5220 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
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: Capillary blood collection tube IVD, no additive
QBC Diagnostics by Drucker Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K891276 also covers:
- QBC Diagnostics — DRUCKER DIAGNOSTICS
- QBC Diagnostics — DRUCKER DIAGNOSTICS
- QBC Diagnostics — DRUCKER DIAGNOSTICS
- QBC Diagnostics — DRUCKER DIAGNOSTICS
- QBC Diagnostics — DRUCKER DIAGNOSTICS
- QBC Diagnostics — DRUCKER DIAGNOSTICS
- QBC Diagnostics — DRUCKER DIAGNOSTICS
- QBC Diagnostics — DRUCKER DIAGNOSTICS
- QBC Diagnostics — DRUCKER DIAGNOSTICS
- QBC Diagnostics — DRUCKER DIAGNOSTICS
- QBC Diagnostics — DRUCKER DIAGNOSTICS
- QBC Diagnostics — DRUCKER DIAGNOSTICS
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
- Drucker Diagnostics
Sources (1)
- FDA UDI 8e78e630-f64d-42a8-83af-a6eb2e7bad9f 35 fields · synced May 30, 2026