FDA UDI
In Commercial Distribution
🇺🇸 United States
H.P.C. (Human Platelet Concentrate)
DI: 10888234001027
·
Model: 0057320
·
IMMUCOR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- H.P.C. (Human Platelet Concentrate)
- Primary DI
- 10888234001027
- Version / Model
- 0057320
- Catalog Number
- 0057320
- Company Name
- IMMUCOR, INC.
- Labeler DUNS
- 061446282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-18
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4f58da61-ab5b-4ec4-8603-637280b534c0
Device Description
H.P.C. (Human Platelet Concentrate) is used to reduce or remove HLA (Bg) activity from serum as an aid in antibody detection and identification. H.P.C. is a dry preparation of a washed pool of platelets from individual human platelet donors. This product is a dry preparation which must be rehydrated before use. This product configuration has ten (10) vials.
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 |
|---|---|---|---|---|
| MYP | Test,Platelet Antibody | Unknown | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56568 | Multiple human platelet antigen (HPA) typing IVD, kit, agglutination | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple human platelet antigen (HPA) systems which may include HPA-1, HPA-2, HPA-3, HPA-4, HPA-5 and/or HPA-15 in a clinical specimen, using an agglutination method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888234001027 | GS1 |
Customer Contacts
- Phone
- 1-855-466-8267
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK850008 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 10 Degrees Celsius