FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Pak2-LE
DI: 10888234500230
·
Model: PAK2-LE
·
IMMUCOR GTI DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pak2-LE
- Primary DI
- 10888234500230
- Version / Model
- PAK2-LE
- Catalog Number
- PAK2-LE
- Company Name
- IMMUCOR GTI DIAGNOSTICS, INC.
- Labeler DUNS
- 606034197
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-08
- Public Version
- 4
- Public Version Date
- 2018-08-01
- Public Version Status
- Update
- Public Device Record Key
- 9ac0cd8c-70c5-414c-825c-00583a6c5329
- Distribution End Date
- 2017-12-15
Device Description
Pak2-LE is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 56573 | Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used in screening and/or identification of one or multiple antibodies to 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 enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888234500230 | GS1 |
Customer Contacts
- Phone
- 855-466-8267
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK950004 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius