Identity
- Trade Name
- AccuDiag ™ FDA UDI
- Generic Name
- SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AccuDiag ™ SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) The SS-A Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to SSA in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSA or anti-Ro antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI
- Model / Reference
- DACD-2555-2 FDA UDI
- Description
- AccuDiag ™ SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) The SS-A Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to SSA in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSA or anti-Ro antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI
Identifiers
- Catalog Number
- 2555-2 FDA UDI
- Primary DI / UDI-DI
- 00894175000213 FDA UDI
- FDA Product Code
- LJM FDA UDI
- GMDN Term
- SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 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: SSA/Ro antibody (Sjogren's 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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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 b9138d6e-e560-4b88-a7a3-37c9e93a31cc 37 fields · synced Jun 8, 2026