FDA UDI
In Commercial Distribution
🇺🇸 United States
QUANTA Flash® LKM-1 Reagents
DI: 08426950767008
·
Model: 701298
·
INOVA DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- QUANTA Flash® LKM-1 Reagents
- Primary DI
- 08426950767008
- Version / Model
- 701298
- Company Name
- INOVA DIAGNOSTICS, INC.
- Labeler DUNS
- 188354831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- cc7744cc-d3fc-4379-a89e-a7efbe3d6fd3
Device Description
1. QUANTA Flash LKM-1 reagent cartridge contains the following reagents for 50 determinations: a. LKM-1 coated paramagnetic beads, lyophilized. b. Assay buffer – colored pink, containing protein stabilizers and preservatives. c. Tracer IgG – Isoluminol labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative. 2. Resuspension buffer - colored clear, containing buffer, protein stabilizers and preservatives."
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 |
|---|---|---|---|---|
| NBS | Autoantibodies,Lkm-1(Liver/Kidney Microsome,Type 1) | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62607 | Liver-kidney microsome 1 antibody (anti-LKM1) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to liver-kidney microsome 1 protein (anti-LKM1) in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to aid in the diagnosis of autoimmune hepatitis type 2. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950767008 | GS1 |
Customer Contacts
- Phone
- 1-800-545-9495
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163538 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius