Identity
- Trade Name
- QUANTA Flash EUDAMEDQUANTA Flash® ENA7 Controls FDA UDI
- Generic Name
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, control FDA UDI
- Device Name
- QUANTA Flash® ENA7 Controls EUDAMED1. QUANTA Flash ENA7 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to ENA7 in buffer, stabilizers, and preservatives. 2. QUANTA Flash ENA7 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to ENA7 in buffer, stabilizers, and preservatives." FDA UDI
- Model / Reference
- 701257 EUDAMEDFDA UDI
- Description
- 1. QUANTA Flash ENA7 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to ENA7 in buffer, stabilizers, and preservatives. 2. QUANTA Flash ENA7 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to ENA7 in buffer, stabilizers, and preservatives." FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950566380 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950566380 EUDAMED
- 510(k) Number
- K122923 FDA UDI
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152011 CONTROLS FOR AUTOIMMUNITY EUDAMED
- GMDN Term
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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-08426950566380 | 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 569db4e3-7367-4cea-9e95-e47a6d404fe5 61 fields · synced Aug 4, 2026
- FDA UDI 033f3331-ab69-4bec-a204-0615471092f2 36 fields · synced May 29, 2026