FDA UDI
In Commercial Distribution
🇺🇸 United States
QUANTA Lite® SLA ELISA
DI: 08426950593706
·
Model: 708775
·
INOVA DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QUANTA Lite® SLA ELISA
- Primary DI
- 08426950593706
- Version / Model
- 708775
- Company Name
- INOVA DIAGNOSTICS, INC.
- Labeler DUNS
- 188354831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2021-08-24
- Public Version Status
- Update
- Public Device Record Key
- 175079a5-ed9c-4464-b2d1-c44caa6ad740
Device Description
(Soluble Liver Antigen) 1.1x SLA ELISA microwell plate (12-1 x 8 wells), with holder 2.1x 1.2mL prediluted ELISA Negative Control 3.1x 1.2mL prediluted SLA ELISA Low Positive 4.1x 1.2mL prediluted SLA ELISA High Positive 5.1x 50mL HRP Sample Diluent 6.1x 25mL HRP Wash Concentrate, 40x concentrate 7.1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8.1x 10mL TMB Chromogen 9.1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
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 |
|---|---|---|---|---|
| NIY | Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55168 | Soluble liver antigen/liver pancreas (SLA/LP) 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 antibodies to soluble liver antigen/liver pancreas (SLA/LP) in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is typically used as an aid in the diagnosis of autoimmune hepatitis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950593706 | GS1 |
Customer Contacts
- Phone
- 1-800-545-9495
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021482 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius