Identity
- Trade Name
- QUANTA Flash EUDAMEDQUANTA Flash® LKM-1 Reagents FDA UDI
- Generic Name
- Liver-kidney microsome 1 antibody (anti-LKM1) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- QUANTA Flash® LKM-1 Reagents EUDAMED1. 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." FDA UDI
- Model / Reference
- 701298 EUDAMEDFDA UDI
- 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." FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950767008 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950767008 EUDAMED
- 510(k) Number
- K163538 FDA UDI
- FDA Product Code
- NBS FDA UDI
- EMDN Code
- W0102100703 LKM1 AND RELATED PROTEINS ANTIBODIES EUDAMED
- GMDN Term
- Liver-kidney microsome 1 antibody (anti-LKM1) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
QUANTA Flash by Inova Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08426950767008 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics. Inc.
- EUDAMED SRN
- US-MF-000017851
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 6df077b3-4f49-4783-b7c4-64dadf846ba6 61 fields · synced May 31, 2026
- FDA UDI cc7744cc-d3fc-4379-a89e-a7efbe3d6fd3 36 fields · synced May 29, 2026