Identity
- Trade Name
- Antiserum to Human IgG FDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, reagent FDA UDI
- Model / Reference
- 9232 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52592320 FDA UDI
- FDA Product Code
- CFF FDA UDI
- GMDN Term
- Immunoglobulin G subclass (IgG subclass) 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
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
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: Immunoglobulin G subclass (IgG subclass) IVD, reagent
Antiserum to Human IgG by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Immunoglobulin G subclass (IgG subclass) IVD, reagent.
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- DImension Vista® Immunoglobulin G Subclass 3 Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- N Latex IgG4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- N AS IgG2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- DImension Vista® Immunoglobulin G Subclass 1 Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
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- TO DISCONTINUE IN US: Isotype Reagent Mo IgG2b/FITC — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Isotype Reagent Mo IgG1/APC — 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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI 9e9f2159-bd89-4d0f-85a6-565cb0480c4a 33 fields · synced Jun 9, 2026