FDA UDI
In Commercial Distribution
🇺🇸 United States
SeCore™ CDx HLA A Locus Sequencing Kit
DI: 00812117016818
·
Model: SECCDX-A
·
ONE LAMBDA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SeCore™ CDx HLA A Locus Sequencing Kit
- Primary DI
- 00812117016818
- Version / Model
- SECCDX-A
- Catalog Number
- SECCDX-A
- Company Name
- ONE LAMBDA, INC.
- Labeler DUNS
- 118289289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-30
- Public Version
- 1
- Public Version Date
- 2023-02-07
- Public Version Status
- New
- Public Device Record Key
- 76159ba0-7c69-471a-917c-fd0c4221a7d6
Device Description
The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| QUK | Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test | Immunology | 866.5960 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56398 | HLA class I & II antigen tissue typing IVD, kit, multiplex | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I and II antigens in a clinical specimen, using a multiplex method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812117016818 | GS1 |
Customer Contacts
- Phone
- 800.822.8824
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -10 Degrees Celsius