Identity
- Trade Name
- IHC FDA UDI
- Generic Name
- Preferentially expressed antigen in melanoma (PRAME) IVD, antibody FDA UDI
- Device Name
- RM55-01: PRAME, Clone EPR20330, 1mL Concentrate FDA UDI
- Model / Reference
- Antibody PRAME Conc Rabbit Monoclonal 1mL FDA UDI
- Description
- RM55-01: PRAME, Clone EPR20330, 1mL Concentrate FDA UDI
Identifiers
- Catalog Number
- RM60-1 FDA UDI
- Primary DI / UDI-DI
- 00810170551932 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Preferentially expressed antigen in melanoma (PRAME) IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
Ihc by Slmp, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Preferentially expressed antigen in melanoma (PRAME) IVD, antibody.
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- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class C
- iFlash-Total β HCG — SHENZHEN YHLO BIOTECH CO., LTD. · Class C
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
- Slmp, LLC
Sources (1)
- FDA UDI 8bcfc7c7-449c-4fd6-9e1c-269f4d814cc1 34 fields · synced Jun 1, 2026