FDA UDI
In Commercial Distribution
🇺🇸 United States
ACCURUN®
DI: 00816784020147
·
Model: 2000-0035
·
Lgc Clinical Diagnostics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACCURUN®
- Primary DI
- 00816784020147
- Version / Model
- 2000-0035
- Catalog Number
- 2000-0035
- Company Name
- Lgc Clinical Diagnostics, Inc.
- Labeler DUNS
- 106267123
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 4
- Public Version Date
- 2023-07-25
- Public Version Status
- Update
- Public Device Record Key
- c6ea0304-c9b2-4428-93b9-a556c0d98e73
Device Description
ACCURUN 26 ToRC IgM Series 5000 3 x 1.0 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
- Yes
- 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 |
|---|---|---|---|---|
| DGQ | Whole Blood Plasma, Antigen, Antiserum, Control | Immunology | 866.5700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48198 | Multiple infectious organism/newborn TORCH screen 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 immunoglobulin G (IgG) and/or immunoglobulin M (IgM) antibodies to organisms in a clinical specimen, as part of an antenatal or newborn infection TORCH screen. The assay is intended to detect infection by multiple organisms that include Toxoplasma gondii, Rubella virus, Cytomegalovirus (CMV), Herpes simplex virus 1 (HSV1), Herpes simplex virus 2 (HSV2), human immunodeficiency virus 1 (HIV1), measles virus and/or Treponema pallidum, and sometimes additional organisms. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816784020147 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -10 Degrees Celsius