FDA UDI
In Commercial Distribution
🇺🇸 United States
ASI RPR Card Test for Syphilis
DI: 00816057021802
·
Model: NC-900500EX
·
ARLINGTON SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ASI RPR Card Test for Syphilis
- Primary DI
- 00816057021802
- Version / Model
- NC-900500EX
- Catalog Number
- NC-900500EX
- Company Name
- ARLINGTON SCIENTIFIC, INC.
- Labeler DUNS
- 785966607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-19
- Public Version
- 1
- Public Version Date
- 2023-12-27
- Public Version Status
- New
- Public Device Record Key
- 0abb737a-6f90-4105-ac76-c38195c6b416
Device Description
Syphilis Screening Test with reactive and nonreactive controls. 500 test kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| GMP | Antisera, Control For Nontreponemal Tests | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816057021802 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K851504 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius