Identity
- Trade Name
- HEp-2000® Colorzyme® ANA-Ro Test System FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- HEp-2000® ANA-Ro Colorzyme® Test System - 260 Tests FDA UDI
- Model / Reference
- 4200-Ro FDA UDI
- Description
- HEp-2000® ANA-Ro Colorzyme® Test System - 260 Tests FDA UDI
Identifiers
- Catalog Number
- 4200-Ro FDA UDI
- Primary DI / UDI-DI
- M7494200RO1 FDA UDI
- GMDN Term
- Multiple antinuclear antibody (ANA) screening 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
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
Yes
FDA UDI
Category: Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
HEp-2000® Colorzyme® ANA-Ro Test System by Immuno Concepts Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ELISA ANA Screen Smart Kit Test System — ZEUS SCIENTIFIC, INC.
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Immuno Concepts Inc
Sources (1)
- FDA UDI 90f55823-04dc-4c9c-af9c-cfd9a4c91e4f 34 fields · synced May 30, 2026