FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OpsisDx
DI: B550ENT0100
·
Model: Quality Control Tray
·
ENTOPSIS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- OpsisDx
- Primary DI
- B550ENT0100
- Version / Model
- Quality Control Tray
- Catalog Number
- ENT010
- Company Name
- ENTOPSIS, LLC
- Labeler DUNS
- 078294784
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-26
- Public Version
- 2
- Public Version Date
- 2024-04-12
- Public Version Status
- Update
- Public Device Record Key
- 61d71847-c051-4734-825c-be0ffa46eefd
- Distribution End Date
- 2023-01-01
Device Description
Metal tray used for quality control of OpsisDx heater
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47868 | Multiple-type clinical chemistry analyte profile IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B550ENT0100 | HIBCC |