Identity
- Trade Name
- AccuDiag ™ FDA UDI
- Generic Name
- Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AccuDiag ™ Mumps IgM A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Mumps virus in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI
- Model / Reference
- DACD1411-1 FDA UDI
- Description
- AccuDiag ™ Mumps IgM A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Mumps virus in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI
Identifiers
- Catalog Number
- 1411-1 FDA UDI
- Primary DI / UDI-DI
- 00894175000060 FDA UDI
- FDA Product Code
- LJY FDA UDI
- GMDN Term
- Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3380 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
No
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: Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ by Diagnostic Automation, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).
- SeraQuest — QUEST INTERNATIONAL, INC. · Class I
- ASI Mumps IgM EIA Test — Arlington Scientific, Inc.
- Trinity Biotech — CLARK LABORATORIES, INC. · Class I
- Trinity Biotech — CLARK LABORATORIES, INC. · Class I
- ReQuest — QUEST INTERNATIONAL, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostic Automation, Inc.
Sources (1)
- FDA UDI 02a80806-8f24-485a-9088-2b4a65a2d808 37 fields · synced May 30, 2026