Identity
- Trade Name
- K-ASSAY® IgG Reagent FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, reagent FDA UDI
- Device Name
- For the quantitative determination of human IgG in serum by immunoturbidimetric assay. FDA UDI
- Model / Reference
- KAI-014 FDA UDI
- Description
- For the quantitative determination of human IgG in serum by immunoturbidimetric assay. FDA UDI
Identifiers
- Catalog Number
- KAI-014 FDA UDI
- Primary DI / UDI-DI
- 00816426020108 FDA UDI
- 510(k) Number
- K993281 FDA UDI
- FDA Product Code
- DEW FDA UDI
- GMDN Term
- Total immunoglobulin G (IgG total) IVD, reagent 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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, reagent
K-ASSAY® IgG Reagent by Kamiya Biomedical Company, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin G (IgG total) IVD, reagent.
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- Anti-Human IgG - Particle - ASR pack — The Binding Site Group · 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
- Control Reagent Rb F(ab')2/FITC + Rb F(ab')2/RPE — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Kamiya Biomedical Company, Llc
Sources (1)
- FDA UDI bb310ce2-c795-44c1-a0f8-1c458ce9f0a6 37 fields · synced May 30, 2026