Identity
- Trade Name
- ELISA ENA Profile-6 Test System FDA UDI
- Generic Name
- Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA ENA Profile-6 Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Jo-1, Sm, Sm/RNP, SSA(Ro), SSB(La), and Scl-70 in human sera. When performed according to these instructions, the results of this autoantibody profile may aid in the diagnosis and treatment of autoimmune connective tissue disorders. This device is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- 2Z2801G FDA UDI
- Description
- The ZEUS ELISA ENA Profile-6 Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Jo-1, Sm, Sm/RNP, SSA(Ro), SSB(La), and Scl-70 in human sera. When performed according to these instructions, the results of this autoantibody profile may aid in the diagnosis and treatment of autoimmune connective tissue disorders. This device is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 2Z2801G FDA UDI
- Primary DI / UDI-DI
- 00845533000550 FDA UDI
- GMDN Term
- Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
ELISA ENA Profile-6 Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Jo-1 antibody IVD, kit, enzyme immunoassay (EIA).
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- ReQuest — QUEST INTERNATIONAL, INC. · Class II
- Jo-1 IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Anti-Jo-1 ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
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 9bde5f84-4d6e-4693-8d2a-14954942cb51 35 fields · synced May 30, 2026