Identity
- Trade Name
- ProSorb-G 2 ml 50 Test FDA UDI
- Generic Name
- Human immunoglobulin M (IgM) animal conjugate antibody reagent IVD FDA UDI
- Device Name
- IgG Removal Reagent FDA UDI
- Model / Reference
- CB004 FDA UDI
- Description
- IgG Removal Reagent FDA UDI
Identifiers
- Catalog Number
- CB004 FDA UDI
- Primary DI / UDI-DI
- 00813545023843 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Human immunoglobulin M (IgM) animal conjugate antibody reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
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: Human immunoglobulin M (IgM) animal conjugate antibody reagent IVD
ProSorb-G 2 ml 50 Test by Scimedx Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human immunoglobulin M (IgM) animal conjugate antibody reagent IVD.
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- Tissue-Tek Genie® — Sakura Finetek USA, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Scimedx Corp.
Sources (1)
- FDA UDI 3e9bcf1e-f2f5-4731-a173-ccb48b82077f 35 fields · synced May 30, 2026