Identity
- Trade Name
- IFA ANA Hep-2 w/Evans Blue Bulk Test System FDA UDI
- Generic Name
- Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The ZEUS IFA ANA HEp-2 Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- FA2400EB FDA UDI
- Description
- The ZEUS IFA ANA HEp-2 Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- FA2400EB FDA UDI
- Primary DI / UDI-DI
- 00845533001397 FDA UDI
- GMDN Term
- Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- 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
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
No
FDA UDI
Category: Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay
IFA ANA Hep-2 w/Evans Blue Bulk Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay.
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- Rat Kidney/Stomach/Liver Tissue — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI a4a23e85-e532-46c1-aead-cefddc9b87f5 35 fields · synced Jun 1, 2026