FDA UDI
In Commercial Distribution
🇺🇸 United States
ACCURUN®
DI: 00816784020871
·
Model: 2000-0005
·
Lgc Clinical Diagnostics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACCURUN®
- Primary DI
- 00816784020871
- Version / Model
- 2000-0005
- Catalog Number
- 2000-0005
- Company Name
- Lgc Clinical Diagnostics, Inc.
- Labeler DUNS
- 106267123
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-01
- Public Version
- 5
- Public Version Date
- 2023-07-25
- Public Version Status
- Update
- Public Device Record Key
- 00b681a2-24b1-4fc8-aa7e-255d8710a536
Device Description
ACCURUN 1 Series 2700 Multi-Marker Positive Control 6 x 3.5 mL
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
- 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 |
|---|---|---|---|---|
| KSF | Kit, Quality Control For Blood Banking Reagents | Hematology | 864.9650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42652 | Multiple blood-borne virus antigen/antibody IVD, control | A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of antigens and/or antibodies from one or multiple blood-borne viruses, in a clinical specimen. Viruses intended to be detected may include (but are not limited to) human immunodeficiency virus 1 and 2 (HIV1 and HIV2), Hepatitis B virus, Hepatitis C virus and human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816784020871 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK930027 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius