FDA UDI
In Commercial Distribution
🇺🇸 United States
AccuDiag ™
DI: 00850049545693
·
Model: DACD1302-1
·
Diagnostic Automation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AccuDiag ™
- Primary DI
- 00850049545693
- Version / Model
- DACD1302-1
- Catalog Number
- 1302-1
- Company Name
- Diagnostic Automation, Inc.
- Labeler DUNS
- 878252071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-14
- Public Version
- 1
- Public Version Date
- 2023-06-22
- Public Version Status
- New
- Public Device Record Key
- 28f479d2-35f4-4872-b932-46d5cb0e0d97
Device Description
AccuDiag ™ Rubella IgM Enzyme- Linked Immunosorbent Assay (ELISA) is intended for the in vitro qualitative determination of IgM antibodies in human serum and as an aid in the diagnosis of current or recent infection with Rubella virus
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
- 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 |
|---|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | Microbiology | 866.3510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50268 | Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Rubella virus in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850049545693 | GS1 |
Customer Contacts
- Phone
- 818-591-3030
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 96 tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius