FDA UDI
In Commercial Distribution
🇺🇸 United States
IH-Card ABO Neutral
DI: 03610522055685
·
Model: 12008722
·
Bio-Rad Medical Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IH-Card ABO Neutral
- Primary DI
- 03610522055685
- Version / Model
- 12008722
- Catalog Number
- 12008722
- 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
- 2022-03-09
- Public Version
- 1
- Public Version Date
- 2022-03-17
- Public Version Status
- New
- Public Device Record Key
- cc66ca6a-b6c2-4fc1-9938-ca0481c62616
Device Description
The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KSZ | System, Test, Automated Blood Grouping And Antibody | Hematology | 864.9175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52710 | Column agglutination IVD | A non-reactive suspension medium containing beaded particles, with or without added agglutination enhancing reagents (e.g., LISS, enzymes), presented as a a set of gels or solid phase columns and intended to be used in testing a clinical specimen for red blood cell antigens and/or antibodies, using a column agglutination technique. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03610522055685 | GS1 |
Customer Contacts
- Phone
- 800-224-6723
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK210625 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius