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FLEX Negative Control Mo Cocktail of Mo IgG1, IgG2a, IgG2b, IgG3 and IgM RTU
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- FLEX Negative Control Mo Cocktail of Mo IgG1, IgG2a, IgG2b, IgG3 and IgM RTU 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 (Dako Autostainer/ Autostainer Plus) FDA UDI
- Model / Reference
- IS750 FDA UDI
- Description
- FLEX Negative Control Mouse Cocktail of mouse IgG1, IgG2a, IgG2b, IgG3 and IgM Ready-to-Use (Dako Autostainer/ Autostainer Plus) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571101919 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
- Not 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
FLEX Negative Control Mo Cocktail of Mo IgG1, IgG2a, IgG2b, IgG3 and IgM RTU by Agilent Technologies Inc. — Class I — FDA UDI — listed in FDA GUDID
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 13cbc4c1-142a-4f0e-9521-6ec137664ad6 37 fields · synced Jun 8, 2026