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FLEX Negative Control Mo Cocktail of Mo IgG1, IgG2a, IgG2b, IgG3, IgM RTU (Link)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- FLEX Negative Control Mo Cocktail of Mo IgG1, IgG2a, IgG2b, IgG3, IgM RTU (Link) FDA UDI
- Generic Name
- Negative control immunoglobulin IVD FDA UDI
- Device Name
- FLEX Negative Control Mouse Cocktail of mouse IgG1, IgG2a, IgG2b, IgG3 and IgM Ready-to-Use (Link) FDA UDI
- Model / Reference
- IR750 FDA UDI
- Description
- FLEX Negative Control Mouse Cocktail of mouse IgG1, IgG2a, IgG2b, IgG3 and IgM Ready-to-Use (Link) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571101773 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Negative control immunoglobulin IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Negative control immunoglobulin IVD
FLEX Negative Control Mo Cocktail of Mo IgG1, IgG2a, IgG2b, IgG3, IgM RTU (Link) by Agilent Technologies Inc. — Class I — FDA UDI — listed in FDA GUDID
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- ACCURUN® — LGC Clinical Diagnostics, Inc.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Inc.
Sources (1)
- FDA UDI cd82e9a0-2e7d-4b83-800e-bf97beb846ce 36 fields · synced Jun 1, 2026