Identity
- Trade Name
- IgM FDA UDI
- Generic Name
- Total immunoglobulin M (IgM total) IVD, antibody FDA UDI
- Device Name
- For the quantitative in vitro determination of IgM in serum and plasma FDA UDI
- Model / Reference
- IM3834 FDA UDI
- Description
- For the quantitative in vitro determination of IgM in serum and plasma FDA UDI
Identifiers
- Catalog Number
- IM3834 FDA UDI
- Primary DI / UDI-DI
- 05055273204001 FDA UDI
- 510(k) Number
- K955797 FDA UDI
- FDA Product Code
- DFT FDA UDI
- GMDN Term
- Total immunoglobulin M (IgM total) IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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 M (IgM total) IVD, antibody
IgM by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin M (IgM total) IVD, antibody.
- Poly Rb A-Hu IgM — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Poly Rb A-Hu IgM/FITC Rb F(ab')2 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- IHC — Slmp, LLC · Class I
- Rhodamine conjugated antiserum to Human IgM — KENT LABORATORIES, INC. · Class II
- Poly Rb a Hu IgM/RPE, Rb F(ab')2 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- IHC — Slmp, LLC · Class I
- IgM RID plate package — KENT LABORATORIES, INC. · Class II
- Peroxidase conjugated antiserum to Human IgM — KENT LABORATORIES, INC. · Class II
Cleared under the same submission
K955797 also covers:
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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI cc55e1d5-ed9c-4888-a502-deb72230fcbc 37 fields · synced Jun 8, 2026