FDA UDI
In Commercial Distribution
🇺🇸 United States
IH-Reader 24
DI: 07611969205486
·
Model: 001200
·
Bio-Rad Medical Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IH-Reader 24
- Primary DI
- 07611969205486
- Version / Model
- 001200
- Catalog Number
- 001200
- Company Name
- Bio-Rad Medical Diagnostics GmbH
- Labeler DUNS
- 312576506
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-10
- Public Version
- 3
- Public Version Date
- 2022-03-14
- Public Version Status
- Update
- Public Device Record Key
- ee088105-c1c3-42bf-9711-eae0b8953375
Device Description
A combination centrifuge and reader for IH gel cards
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- 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 | 07611969205486 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK180225 | 0 |