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Negative Control Rb Immunoglobulin Fraction (Solid-Phase Absorbed)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Negative Control Rb Immunoglobulin Fraction (Solid-Phase Absorbed) FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, control FDA UDI
- Device Name
- Negative Control Rabbit Immunoglobulin Fraction (Solid-Phase Absorbed) FDA UDI
- Model / Reference
- X0936 FDA UDI
- Description
- Negative Control Rabbit Immunoglobulin Fraction (Solid-Phase Absorbed) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572009542 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Total immunoglobulin G (IgG total) IVD, control 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
Dimensions & Sizes
- Size
- Total Volume — 2 Milliliter FDA UDI
Category: Total immunoglobulin G (IgG total) IVD, control
Negative Control Rb Immunoglobulin Fraction (Solid-Phase Absorbed) by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Total immunoglobulin G (IgG total) IVD, control.
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- Human IgG Control Pack for use on the SPAPLUS® — The Binding Site Group · Class I
- IgG control slides — BIO SB, INC. · Class I
- Peroxidase conjugated Antiserum to Human IgG — KENT LABORATORIES, INC. · Class II
- IgG RID Plate Package — KENT LABORATORIES, INC. · Class II
- Anti Human Immunoglobulins IgG, IgA, and IgM FITC — KENT LABORATORIES, INC. · 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 a5fb8968-3a30-48b0-84d8-e01fd08e7671 36 fields · synced May 30, 2026