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SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells
FDA UDIClass N (US FDA UDI)
Identity
- Trade Name
- SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 12525-300 FDA UDI
Identifiers
- Catalog Number
- 12525-300B FDA UDI
- Primary DI / UDI-DI
- 00816870024875 FDA UDI
- FDA Product Code
- QKO FDA UDI
- GMDN Term
- SARS-CoV-2 immunoglobulin G (IgG) 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
No
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 7.75 Inch FDA UDI
Category: SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells by Monobind, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- Anti-SARS-CoV-2 ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · N
- SCoV-2 Detect™ IgG ELISA — InBios International, Inc. · N
- SARS-CoV-2 IgG ELISA Kit — Agilent Technologies Inc. · N
- SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · N
- SARS-CoV-2 IgG AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · N
- SARS-CoV-2 IgG AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · N
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 |
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Manufacturer
- Manufacturer
- Monobind, Inc.
Sources (1)
- FDA UDI 197b0303-c976-498e-adfe-a0b272310694 36 fields · synced Jun 8, 2026