FDA UDI
In Commercial Distribution
🇺🇸 United States
AIX1000 Performance Check Dye Kit
DI: B350GSD011600DYE0
·
Model: GSD01-1600-DYE
·
Gold Standard Diagnostics Corporation
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AIX1000 Performance Check Dye Kit
- Primary DI
- B350GSD011600DYE0
- Version / Model
- GSD01-1600-DYE
- Catalog Number
- GSD01-1600-DYE
- Company Name
- Gold Standard Diagnostics Corporation
- Labeler DUNS
- 790524891
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-13
- Public Version
- 3
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- 355c6891-08e2-4219-adf0-c43cfdddb994
Device Description
AIX1000 Performance Check Dye Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GMQ | Antigens, Nontreponemal, All | Microbiology | 866.3820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51819 | Treponema pallidum reagin antibody IVD, kit, agglutination | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis. | No | Active |
| 65827 | Optical laboratory instrument performance standard calibrator/control | A reference standard solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimize the performance of an optical laboratory instrument/analyser (e.g., spectrophotometer, nephelometer, automated microplate reader, PCR instrument). Verification/optimization functions may include optical density (absorbance/scattering), fluorescent/luminescent accuracy and compensation, linearity at specified wavelengths and/or stray light interference. It is typically used to verify pipetting/dispensing/aspiration/diluting functions of liquid-handling instruments and/or to assess analyser/instrument cleanliness. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B350GSD011600DYE0 | HIBCC |
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Room Temperature