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Zinc Transporter 8 Auto-Antibody (ZnT8)
FDA UDIClass II (US FDA UDI)
by Kronus, Inc.
Identity
- Trade Name
- Zinc Transporter 8 Auto-Antibody (ZnT8) FDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum. FDA UDI
- Model / Reference
- KR7730 FDA UDI
- Description
- An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum. FDA UDI
Identifiers
- Catalog Number
- KR7730 FDA UDI
- Primary DI / UDI-DI
- B126KR77300 FDA UDI
- 510(k) Number
- DEN140001 FDA UDI
- FDA Product Code
- PHF FDA UDI
- GMDN Term
- Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5670 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: Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)
Zinc Transporter 8 Auto-Antibody (ZnT8) by Kronus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA).
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- Aquaporin-4 Auto-Antibody (AQP4Ab) — KRONUS, 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kronus, Inc.
Sources (1)
- FDA UDI 86d3c5a8-4ffe-4151-84e5-41c9f382fc91 36 fields · synced Jun 8, 2026