FDA UDI
In Commercial Distribution
🇺🇸 United States
SUNRISE-RC/ST EVOLYZER
DI: 09120052071191
·
Model: 30087504 02
·
Tecan Austria GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SUNRISE-RC/ST EVOLYZER
- Primary DI
- 09120052071191
- Version / Model
- 30087504 02
- Catalog Number
- 30087504
- Company Name
- Tecan Austria GmbH
- Labeler DUNS
- 301237509
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-06
- Public Version
- 1
- Public Version Date
- 2023-07-14
- Public Version Status
- New
- Public Device Record Key
- a45c7d60-a047-447a-84f2-0dfd545969ed
Device Description
microplate reader - intended to be integrated in robotic solutions
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | Clinical Chemistry | 862.2300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57862 | Microplate reader IVD, automated/semi-automated | An electrically-powered automated or semi-automated laboratory instrument intended to be used to photometrically measure the optical absorbance or emission of clinical specimens in microplates containing multiple individual sample wells, with or without a separate cuvette-reading station. The device utilizes technology which may include reagent dispensing, a single or dual lightsource, bandpass filters, monochromators, photodetectors, data processing software and/or data displays to determine the qualitative and/or quantitative values of biological constituents of a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09120052071191 | GS1 |
Customer Contacts
- Phone
- +18003525128
- [email protected]