FDA UDI
In Commercial Distribution
🇺🇸 United States
DG Reader Net
DI: 08437014205619
·
Model: 210700
·
DIAGNOSTIC GRIFOLS SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DG Reader Net
- Primary DI
- 08437014205619
- Version / Model
- 210700
- Catalog Number
- 210700
- Company Name
- DIAGNOSTIC GRIFOLS SA
- Labeler DUNS
- 463625602
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-27
- Public Version
- 1
- Public Version Date
- 2019-12-05
- Public Version Status
- New
- Public Device Record Key
- d4820fcf-bc6b-4e9e-9933-321b7cda6d13
Device Description
DG Reader Net is a device designed to read, interpret, and report the results of the processed DG Gel 8 cards. The instrument also identifies DG Gel 8 cards by reading their barcodes. As a stand-alone or interfaced to the customer’s Laboratory Information System (LIS), the instrument automates data management requirements using DG Gel 8 cards and digital image processing.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSZ | System, Test, Automated Blood Grouping And Antibody | Hematology | 864.9175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57847 | Immunohaematology/blood bank analyser IVD, semi-automated | A mains electricity (AC-powered) laboratory instrument intended to be used to perform blood grouping, red cell phenotyping, antibody screening, antibody identification, direct antiglobulin tests and/or crossmatching of clinical specimens. It utilizes one or more immunological methods which may include microplate agglutination, column agglutination technology or nephelometry, together with an enzymic, photometric or radiometric detection system, and sample processing, data processing and/or data display software. The device operates with reduced technician involvement and automation of some, but not all, procedural steps. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08437014205619 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK190379 | 0 |