Identity
- Trade Name
- IgG RID Plate Kit FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, control FDA UDI
- Device Name
- Radial immunodiffusion plate package for human human IgG with three standards FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Radial immunodiffusion plate package for human human IgG with three standards FDA UDI
Identifiers
- Catalog Number
- 101511 FDA UDI
- Primary DI / UDI-DI
- B1761015 FDA UDI
- FDA Product Code
- CGM FDA UDI
- GMDN Term
- Total immunoglobulin G (IgG total) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 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: Total immunoglobulin G (IgG total) IVD, control
IgG RID Plate Kit by Kent Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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
- Negative Control Mo IgG1/RPE-Cy5, Cl DAK-GO1 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class II
- IgG control slides — BIO SB, INC. · Class I
- Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum — IMMUCOR, INC. · Class I
- IgG / FITC control slides — BIO SB, INC. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Kent Laboratories, Inc.
Sources (1)
- FDA UDI ae047f42-9f72-4174-92ea-f9b922e803d3 36 fields · synced May 31, 2026