FDA UDI
In Commercial Distribution
🇺🇸 United States
BeadCheck HEA Ref-pA, Bulk and Fill
DI: 10888234102298
·
Model: 800-00228
·
BIOARRAY SOLUTIONS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BeadCheck HEA Ref-pA, Bulk and Fill
- Primary DI
- 10888234102298
- Version / Model
- 800-00228
- Catalog Number
- 800-00228
- Company Name
- BIOARRAY SOLUTIONS LTD
- Labeler DUNS
- 949103725
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4886843b-14dc-43d2-bdbd-292cfd5b1cb2
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
- 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 |
|---|---|---|---|---|
| PFK | Quality Control For Molecular Immunohematology Tests | Hematology | 864.9650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60727 | Multiple blood group genotyping IVD, control | A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to determine the genotype for one or multiple blood groups. The blood group systems to be genotyped may include Rhesus (CcDEe), Kell (K, k, Kp^a, Kp^b), Duffy (Fy^a, Fy^b, Fy^x), Kidd (Jk^a, Jk^b), Lewis (Le^a, Le^b), MNS (M, N, S, s, U), Xg (Xg^a), Dombrock (Do^a, Do^b), Colton (Co^a, Co^b), Cartwright (Yt^a, Yt^b), Lutheran (Lu^a, Lu^b) and/or Diego (Di^a, Di^b). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888234102298 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK130050 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -80 – -20 Degrees Celsius