← Back to catalogue
Antinuclear Antibody HEp-2 Antigen Substrate, 16 wells, For IFA Test System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Antinuclear Antibody HEp-2 Antigen Substrate, 16 wells, For IFA Test System FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, reagent FDA UDI
- Model / Reference
- AN-1016 FDA UDI
Identifiers
- Catalog Number
- AN-1016 FDA UDI
- Primary DI / UDI-DI
- B110AN10160 FDA UDI
- 510(k) Number
- K872845 FDA UDI
- FDA Product Code
- DHN FDA UDI
- GMDN Term
- Multiple antinuclear antibody (ANA) screening IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 FDA UDI
- Commercial Distribution
- Not 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
No
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
Antinuclear Antibody HEp-2 Antigen Substrate, 16 wells, For IFA Test System by Bion Enterprises, Ltd. — Class II — FDA UDI — listed in FDA GUDID
Cleared under the same submission
K872845 also covers:
- ANA (HEp-2) Test System, 120 Tests — BION ENTERPRISES, LTD.
- ANA (HEp-2) Test System, 300 Tests — BION ENTERPRISES, LTD.
- ANA (HEp-2) Test System, 60 Tests — BION ENTERPRISES, LTD.
- ANA Calibrator — BION ENTERPRISES, LTD.
- ANA Homogeneous Control — BION ENTERPRISES, LTD.
- ANA Negative Control — BION ENTERPRISES, LTD.
- ANA Nucleolar Control — BION ENTERPRISES, LTD.
- ANA RNP Control — BION ENTERPRISES, LTD.
- ANA SSA Control — BION ENTERPRISES, LTD.
- ANA SSB Control — BION ENTERPRISES, LTD.
- ANA Scl-70 Control — BION ENTERPRISES, LTD.
- Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System — BION ENTERPRISES, LTD.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bion Enterprises, Ltd.
Sources (1)
- FDA UDI c76ec973-0144-42d8-842d-4eeb1da16406 37 fields · synced May 30, 2026