Identity
- Trade Name
- ELISA Scl-70 Test System FDA UDI
- Generic Name
- Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Scl-70 Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Scl-70 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. This device is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- 2Z2861G FDA UDI
- Description
- The ZEUS ELISA Scl-70 Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Scl-70 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. This device is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 2Z2861G FDA UDI
- Primary DI / UDI-DI
- 00845533001052 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
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: Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)
ELISA Scl-70 Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA).
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- Anti-Scl-70 ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit — Gold Standard Diagnostics, LLC · Class II
- EL-ANA Profiles: anti-Scl-70 — THERATEST LABORATORIES, INC.
- Anti-Scl-70 ELISA — DRG International, Inc. · Class II
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 ceef9337-6de6-4344-8760-faa5a0dcc795 35 fields · synced Jun 1, 2026