Identity
- Trade Name
- CD163 R-PE FDA UDI
- Generic Name
- CD163 cell marker IVD, antibody FDA UDI
- Device Name
- The R-PE conjugated monoclonal antibody CD163 (clone MAC2-158) detects human CD163. It targets an epitope within the SRCR1 domain from the N-terminal region. FDA UDI
- Model / Reference
- IQP-570R FDA UDI
- Description
- The R-PE conjugated monoclonal antibody CD163 (clone MAC2-158) detects human CD163. It targets an epitope within the SRCR1 domain from the N-terminal region. FDA UDI
Identifiers
- Catalog Number
- IQP-570R FDA UDI
- Primary DI / UDI-DI
- 08719327451038 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- CD163 cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
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: CD163 cell marker IVD, antibody
Cd163 R-Pe by IQ Products B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CD163 cell marker IVD, antibody.
- CD163 (MRQ-26) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Tinto CD163, RMab — BIO SB, INC. · Class I
- Tinto CD163, RMab — BIO SB, INC. · Class I
- Novocastra — Leica Biosystems Newcastle, Limited · Class I
- CD163 (MRQ-26) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- CD163 — BIOCARE MEDICAL, LLC · Class I
- Rabbit Monoclonal Anti-Human CD163 Antibody, EP324 — EPITOMICS, INC. · Class I
- Mouse Monoclonal Anti-Human CD163(MX081) Antibody — Fuzhou Maixin Biotech Co., 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 I | Pending data |
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Manufacturer
- Manufacturer
- IQ Products B.V.
Sources (1)
- FDA UDI 7bf7b232-9fad-44b2-990f-e2ca901a1190 36 fields · synced May 30, 2026