Identity
- Trade Name
- Control Reagent Rb F(ab')2/FITC + Rb F(ab')2/RPE FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, reagent FDA UDI
- Device Name
- MultiMix Dual-Colour Control Reagent Rabbit F(ab')2/FITC Rabbit F(ab')2/RPE FDA UDI
- Model / Reference
- X0935 FDA UDI
- Description
- MultiMix Dual-Colour Control Reagent Rabbit F(ab')2/FITC Rabbit F(ab')2/RPE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572516590 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Total immunoglobulin G (IgG total) 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 — 0.5 Milliliter FDA UDI
Category: Total immunoglobulin G (IgG total) IVD, reagent
Control Reagent Rb F(ab')2/FITC + Rb F(ab')2/RPE by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Total immunoglobulin G (IgG total) IVD, reagent.
- Anti-Human IgG - Particle - ASR pack — The Binding Site Group · Class I
- K-ASSAY® IgG Reagent — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
- Ig Reagent Rb F(ab')2/APC — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Control Reagent Rb F(ab')2/FITC + Rb F(ab')2/RPE + Mo IgG1/RPE-Cy5 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Ig Reagent Rb F(ab')2/RPE — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Control Reagent Mo IgG1/FITC + Rb F(ab')2/RPE + Rb F(ab')2/APC — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Ig Reagent Rb F(ab')2/FITC — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Singapore Pte Ltd
Sources (1)
- FDA UDI dc348c69-f367-4b9b-b7ea-377b7f4e1f5f 36 fields · synced Jun 8, 2026