FDA UDI
In Commercial Distribution
🇺🇸 United States
AccuDiag ™
DI: 00894175000336
·
Model: DACD-2550-1
·
Diagnostic Automation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AccuDiag ™
- Primary DI
- 00894175000336
- Version / Model
- DACD-2550-1
- Catalog Number
- 2550-1
- Company Name
- Diagnostic Automation, Inc.
- Labeler DUNS
- 878252071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-06
- Public Version
- 1
- Public Version Date
- 2021-08-16
- Public Version Status
- New
- Public Device Record Key
- 629d9d4b-8b36-43a5-b6fe-bc2dd6c5bad1
Device Description
AccuDiag ™ Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) The Diagnostic Automation Rheumatoid Factor (RF) Enzyme-Linked Immu-nosorbent Assay (ELISA) is intended for the detection of IgM antibodies in human serum to RF antigen and as an aid in the diagnosis of rheumatoid arthritis. For in vitro diagnostic use. High complexity test.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| DHR | System, Test, Rheumatoid Factor | Immunology | 866.5775 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54845 | Multiple rheumatoid arthritis-associated antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with rheumatoid arthritis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at rheumatoid factor (RF) and/or cyclic citrulline peptide. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00894175000336 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 96 Tests (1 Kit) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage and Handling Storage Environment Temperature: between 2 and 8 Degrees Celsius