FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Quantum Blue® Reader
DI: EBUHBIPOCTRABS0
·
Model: BI-POCTR-ABS
·
Bühlmann Laboratories AG
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Quantum Blue® Reader
- Primary DI
- EBUHBIPOCTRABS0
- Version / Model
- BI-POCTR-ABS
- Company Name
- Bühlmann Laboratories AG
- Labeler DUNS
- 481261006
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-12
- Public Version
- 3
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- e28ce1d1-bcfa-4da6-8117-0b04d86b944b
- Distribution End Date
- 2021-01-12
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42625 | Photometric/spectroscopic immunoassay analyser IVD | An electrically-powered instrument intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card), after vehicle exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in the clinical specimen. The instrument uses photometry and/or light spectroscopy to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by healthcare professionals for rapid in vitro diagnostic measurements [e.g., lateral flow immunochromatographic (ICT) test] at the point-of-care or in the laboratory. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EBUHBIPOCTRABS0 | HIBCC |
Customer Contacts
- Phone
- (844) 300-9799
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius