FDA UDI
In Commercial Distribution
🇺🇸 United States
QBC Diagnostics
DI: 00858092006468
·
Model: 4277-112-300
·
DRUCKER DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
250
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Basic Information
- Brand Name
- QBC Diagnostics
- Primary DI
- 00858092006468
- Version / Model
- 4277-112-300
- Company Name
- DRUCKER DIAGNOSTICS
- Labeler DUNS
- 022156957
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- c9898ac5-6ab4-4978-a2e0-41b947307459
Device Description
Malaria Tube - Blood Collection Device (250 Tube Box); Inner Labeled Package of Malaria 2000 Test Kit (253005) *NOT A SOLD PRODUCT*
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GKZ | Counter, Differential Cell | Hematology | 864.5220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52311 | Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple species of Plasmodium, the malaria parasites (e.g., P. falciparum, P. vivax, P. ovale, P. knowlesi, P. malariae), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858092006468 | GS1 | ||||
| Unit of Use | 00858092006338 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K891276 | 000 |