FDA UDI
In Commercial Distribution
🇺🇸 United States
INFINITE 200 PRO
DI: 09120052070521
·
Model: 30050303 01
·
Tecan Austria GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INFINITE 200 PRO
- Primary DI
- 09120052070521
- Version / Model
- 30050303 01
- Catalog Number
- 30050303
- Company Name
- Tecan Austria GmbH
- Labeler DUNS
- 301237509
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-22
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 31ff1058-59e1-4204-a2a2-3ea449944021
Device Description
microplate reader
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 |
| KHO | Fluorometer, For Clinical Use | Clinical Chemistry | 862.2560 | 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 | 09120052070521 | GS1 |
Customer Contacts
- Phone
- +18003525128
- [email protected]