Identity
- Trade Name
- BIO-RAD FDA UDI
- Generic Name
- Microplate/tube/assay card incubator IVD FDA UDI
- Device Name
- IPS FDA UDI
- Model / Reference
- 87530 FDA UDI
- Description
- IPS FDA UDI
Identifiers
- Catalog Number
- 87530 FDA UDI
- Primary DI / UDI-DI
- 03610520014103 FDA UDI
- FDA Product Code
- JRR FDA UDI
- GMDN Term
- Microplate/tube/assay card incubator IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microplate/tube/assay card incubator IVD
Bio-Rad by Bio-Rad — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microplate/tube/assay card incubator IVD.
- ORTHO — Ortho-Clinical Diagnostics · N
- I-UNICELL Incubator — Shenzhen YHLO Biotech Co., Ltd. · Class II
- DG Therm — DIAGNOSTIC GRIFOLS SA · Class II
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
- Bio-Rad
Sources (1)
- FDA UDI f47d4b2f-052c-42d6-ae2f-52be94f8e754 37 fields · synced Jun 6, 2026