FDA UDI
In Commercial Distribution
🇺🇸 United States
LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with Luminex
DI: 10888234400073
·
Model: 628925
·
IMMUCOR GTI DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with Luminex
- Primary DI
- 10888234400073
- Version / Model
- 628925
- Catalog Number
- 628925
- Company Name
- IMMUCOR GTI DIAGNOSTICS, INC.
- Labeler DUNS
- 606034197
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 4
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- 19662d62-c8dc-44b5-aac0-e64c4b9cc2dd
Device Description
DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| MZI | Test,Qualitative,For Hla,Non-Diagnostic | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60117 | DNA-based tissue typing IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose or predict donor and recipient tissue compatibility based on one or multiple genetic markers from the major histocompatibility complex (MHC) family of genes, using a nucleic acid technique (NAT). Genetic markers may include HLA-A, HLA-B, HLA-C, DRB1, DRB3, DRB4, DRB5, DQB1, DPB1, MICA and/or C4. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888234400073 | GS1 |
Customer Contacts
- Phone
- 855-466-8267
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK130075 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away From Light