Identity
- Trade Name
- SCoV-2 Detect™ Neutralizing Ab ELISA FDA UDI
- Generic Name
- SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- COVN-E FDA UDI
Identifiers
- Primary DI / UDI-DI
- B379COVNE1 FDA UDI
- FDA Product Code
- QKO FDA UDI
- GMDN Term
- SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)
SCoV-2 Detect™ Neutralizing Ab ELISA by InBios International, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- InBios International, Inc.
Sources (1)
- FDA UDI 9707906a-42f0-4c26-94a3-ea76df34c5b4 32 fields · synced Jun 9, 2026