Identity
- Trade Name
- Autoimmune EIA FDA UDI
- Generic Name
- Multiple extractable nuclear antigen (ENA) IVD, reagent FDA UDI
- Device Name
- Autoimmune EIA ENA Conjugate, 15 mL FDA UDI
- Model / Reference
- 220HSP FDA UDI
- Description
- Autoimmune EIA ENA Conjugate, 15 mL FDA UDI
Identifiers
- Catalog Number
- 220HSP FDA UDI
- Primary DI / UDI-DI
- 00847817006944 FDA UDI
- 510(k) Number
- K952253 FDA UDI
- FDA Product Code
- LLL FDA UDI
- GMDN Term
- Multiple extractable nuclear antigen (ENA) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 15 Milliliter FDA UDI
Category: Multiple extractable nuclear antigen (ENA) IVD, reagent
Autoimmune EIA by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple extractable nuclear antigen (ENA) IVD, reagent.
- Diamedix — Diamedix Corp. · Class II
Cleared under the same submission
K952253 also covers:
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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI b077adfb-b66f-4972-bf25-92ea7615912e 38 fields · synced May 31, 2026