FDA UDI
In Commercial Distribution
🇺🇸 United States
AccuDiag ™
DI: 00894175000015
·
Model: DACD1412-1
·
Diagnostic Automation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AccuDiag ™
- Primary DI
- 00894175000015
- Version / Model
- DACD1412-1
- Catalog Number
- 1412-1
- 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
- fd72b002-375f-46f1-b793-758a7a1beda6
Device Description
AccuDiag ™ Varicella-Zoster Virus (VZV) IgG Enzyme-linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
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 |
|---|---|---|---|---|
| GQX | Antiserum, Cf, Varicella-Zoster | Microbiology | 866.3900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49621 | Varicella-zoster virus (VZV) immunoglobulin G (IgG) 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 G (IgG) antibodies to varicella-zoster virus (VZV) 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 | 00894175000015 | 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