Identity
- Trade Name
- ACCURUN® FDA UDI
- Generic Name
- Negative control immunoglobulin IVD FDA UDI
- Model / Reference
- 2010-0025 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850041090078 FDA UDI
- GMDN Term
- Negative control immunoglobulin IVD 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Negative control immunoglobulin IVD
Accurun® by LGC Clinical Diagnostics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Simultest — BECTON DICKINSON AND COMPANY · Class II
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- Genemed® — Sakura Finetek USA, Inc · Class I
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
- LGC Clinical Diagnostics, Inc.
Sources (1)
- FDA UDI be19fd6a-e73b-4d7b-b0e9-4c181f42e17c 32 fields · synced Jun 9, 2026