FDA UDI
In Commercial Distribution
🇺🇸 United States
ACCURUN®
DI: 00860006589790
·
Model: 0505-0300
·
Lgc Clinical Diagnostics, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ACCURUN®
- Primary DI
- 00860006589790
- Version / Model
- 0505-0300
- Company Name
- Lgc Clinical Diagnostics, Inc.
- Labeler DUNS
- 106267123
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-02
- Public Version
- 1
- Public Version Date
- 2024-08-12
- Public Version Status
- New
- Public Device Record Key
- 6d522e2b-3275-4248-81e6-a1db3f24d65c
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64748 | SARS-CoV-2 nucleic acid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent for COVID-19, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860006589790 | GS1 |