FDA UDI
In Commercial Distribution
🇺🇸 United States
ABORhCard
DI: 00815312020000
·
Model: BT-101-025
·
MICRONICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- ABORhCard
- Primary DI
- 00815312020000
- Version / Model
- BT-101-025
- Catalog Number
- BT-101-025
- Company Name
- MICRONICS, INC.
- Labeler DUNS
- 799245519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2021-10-19
- Public Version Status
- Update
- Public Device Record Key
- 72bfec55-35dd-4a06-abf9-e720c6e8f824
Device Description
Qualitative in vitro test that provides a simultaneous ABO and Rh determination of an individual's ABO and Rh status. Not for use in blood bank processing of blood products, for determining RHD status for the purpose of administering Rh immunoglobulin, or for screening purposes prior to transfusion. Single use device intended for individual blood group determination for educational and informational purposes. Each kit contains 25 tests.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| OQX | Self-Contained Blood Grouping | Hematology | 864.9175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45308 | ABO/Rh multiple blood grouping IVD, kit, agglutination | A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen for a combination of multiple ABO system and Rh group red blood cell antigens, using an agglutination method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815312020000 | GS1 | ||||
| Unit of Use | 00815312020048 | GS1 |
Customer Contacts
- Phone
- 1-855-895-9197
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK100008 | 0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- store at room temperatuire