FDA UDI
In Commercial Distribution
🇺🇸 United States
QMedix™
DI: 00850054026156
·
Model: DACD1408-1
·
Diagnostic Automation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- QMedix™
- Primary DI
- 00850054026156
- Version / Model
- DACD1408-1
- Catalog Number
- 1408-1
- Company Name
- Diagnostic Automation, Inc.
- Labeler DUNS
- 878252071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-05
- Public Version
- 1
- Public Version Date
- 2025-06-13
- Public Version Status
- New
- Public Device Record Key
- cf3d3622-55ef-4295-afef-27277969f9a9
Device Description
QMedix™ Measles IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibodies to Measles (Rubeola) virus 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 |
|---|---|---|---|---|
| LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | Microbiology | 866.3520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49287 | Measles virus 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 Measles 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 | 00850054026156 | GS1 |
Customer Contacts
- Phone
- 8185913030
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 96 Tests/Kit |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius