Identity
- Trade Name
- AccuDiag ™ FDA UDI
- Generic Name
- Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AccuDiag ™ Rubella IgM Enzyme- Linked Immunosorbent Assay (ELISA) is intended for the in vitro qualitative determination of IgM antibodies in human serum and as an aid in the diagnosis of current or recent infection with Rubella virus FDA UDI
- Model / Reference
- DACD1302-1 FDA UDI
- Description
- AccuDiag ™ Rubella IgM Enzyme- Linked Immunosorbent Assay (ELISA) is intended for the in vitro qualitative determination of IgM antibodies in human serum and as an aid in the diagnosis of current or recent infection with Rubella virus FDA UDI
Identifiers
- Catalog Number
- 1302-1 FDA UDI
- Primary DI / UDI-DI
- 00850049545693 FDA UDI
- FDA Product Code
- LFX FDA UDI
- GMDN Term
- Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3510 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: Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ by Diagnostic Automation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).
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- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- ASI Rubella IgM EIA Test — Arlington Scientific, Inc. · Class II
- ReQuest — QUEST INTERNATIONAL, INC. · Class II
- ELISA Rubella IgM Test System — ZEUS SCIENTIFIC, INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Diagnostic Automation, Inc.
Sources (1)
- FDA UDI 28f479d2-35f4-4872-b932-46d5cb0e0d97 37 fields · synced May 30, 2026