FDA UDI
In Commercial Distribution
🇺🇸 United States
ASI SLE Slide Test Control Set
DI: 00816057021604
·
Model: NC-355001
·
ARLINGTON SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ASI SLE Slide Test Control Set
- Primary DI
- 00816057021604
- Version / Model
- NC-355001
- Catalog Number
- NC355001
- Company Name
- ARLINGTON SCIENTIFIC, INC.
- Labeler DUNS
- 785966607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-08
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a00f603f-e951-4a06-8ccb-2f4cd453b3f3
Device Description
Detection of Asnti-DNP, associated with Systemis Lupus Erythematosus
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| DHC | System, Test, Systemic Lupus Erythematosus | Immunology | 866.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42225 | Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple antibodies associated with systemic lupus erythematosus (SLE) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816057021604 | GS1 |
Customer Contacts
- Phone
- 801-489-8911
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K821385 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius