Identity
- Trade Name
- DG Therm FDA UDI
- Generic Name
- Microplate/tube/assay card incubator IVD FDA UDI
- Device Name
- DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology applications. FDA UDI
- Model / Reference
- 213734 FDA UDI
- Description
- DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology applications. FDA UDI
Identifiers
- Catalog Number
- 213734 FDA UDI
- Primary DI / UDI-DI
- 08437014205169 FDA UDI
- FDA Product Code
- PBC FDA UDI
- GMDN Term
- Microplate/tube/assay card incubator IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9175 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microplate/tube/assay card incubator IVD
DG Therm by Diagnostic Grifols Sa — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- BIO-RAD — Bio-Rad · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostic Grifols Sa
Sources (2)
- FDA UDI 23b51e9f-41a3-4307-8b3a-9183d60a6be5 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026