Identity
- Trade Name
- AccuDiag ™ FDA UDI
- Generic Name
- Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AccuDiag ™Mycoplasma pneumoniae IgM Test System provides a means for the qualitative detection of IgM antibodies to Mycoplasma pneumoniae in human sera. FDA UDI
- Model / Reference
- DACD8043-2 FDA UDI
- Description
- AccuDiag ™Mycoplasma pneumoniae IgM Test System provides a means for the qualitative detection of IgM antibodies to Mycoplasma pneumoniae in human sera. FDA UDI
Identifiers
- Catalog Number
- 8043-2 FDA UDI
- Primary DI / UDI-DI
- 00894175000749 FDA UDI
- FDA Product Code
- LJZ FDA UDI
- GMDN Term
- Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3375 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: Mycoplasma pneumoniae 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
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- ELISA M. pneumoniae IgM Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- Trinity Biotech — CLARK LABORATORIES, 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 |
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Manufacturer
- Manufacturer
- Diagnostic Automation, Inc.
Sources (1)
- FDA UDI b66b6a61-75df-4ec5-a166-430949c90caa 37 fields · synced Jun 1, 2026