FDA UDI
In Commercial Distribution
🇺🇸 United States
Diagnostic Automation, Inc.
DI: 00850049545501
·
Model: DAI SF2100
·
Diagnostic Automation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diagnostic Automation, Inc.
- Primary DI
- 00850049545501
- Version / Model
- DAI SF2100
- Catalog Number
- SF2100
- Company Name
- Diagnostic Automation, Inc.
- Labeler DUNS
- 878252071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-24
- Public Version
- 1
- Public Version Date
- 2026-01-01
- Public Version Status
- New
- Public Device Record Key
- 49c5ec31-63f9-4015-a616-ef548c5bde6a
Device Description
Stat Fax 2100 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 | 00850049545501 | GS1 |
Customer Contacts
- Phone
- 8185913030
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K900224 | 000 |