Identity
- Trade Name
- Immunalysis FDA UDI
- Generic Name
- Immunohistochemistry antibody diluent IVD FDA UDI
- Device Name
- Enzyme Conjugate Diluent DF General Purpose Reagent (GPR) FDA UDI
- Model / Reference
- GPR-E-188-40 FDA UDI
- Description
- Enzyme Conjugate Diluent DF General Purpose Reagent (GPR) FDA UDI
Identifiers
- Catalog Number
- GPR-E-188-40 FDA UDI
- Primary DI / UDI-DI
- 00840937110164 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Immunohistochemistry antibody diluent 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
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
Yes
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: Immunohistochemistry antibody diluent IVD
Immunalysis by Immunalysis Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Immunalysis Corporation
Sources (1)
- FDA UDI 69b1ad5c-559a-4f58-bcf6-be721e6af617 34 fields · synced Jun 6, 2026