Identity
- Trade Name
- Isotype Reagent Mo IgG2a/RPE FDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, reagent FDA UDI
- Device Name
- Isotype Reagent Mouse IgG2a/RPE FDA UDI
- Model / Reference
- X0950 FDA UDI
- Description
- Isotype Reagent Mouse IgG2a/RPE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572516620 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Immunoglobulin G subclass (IgG subclass) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Immunoglobulin G subclass (IgG subclass) IVD, reagent
Isotype Reagent Mo IgG2a/RPE by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Immunoglobulin G subclass (IgG subclass) IVD, reagent.
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- N Latex IgG4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
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- DImension Vista® Immunoglobulin G Subclass 1 Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- N Latex IgG3 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- DImension Vista® Immunoglobulin G Subclass 2 Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
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 Singapore Pte Ltd
Sources (1)
- FDA UDI 8bce94e9-7b47-4e82-b9dd-eec038b3f630 36 fields · synced May 30, 2026