FDA UDI
In Commercial Distribution
🇺🇸 United States
EnLite Neonatal TREC kit
DI: 06438147331802
·
Model: 3401-001U
·
Wallac Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EnLite Neonatal TREC kit
- Primary DI
- 06438147331802
- Version / Model
- 3401-001U
- Catalog Number
- 3401-001U
- Company Name
- Wallac Oy
- Labeler DUNS
- 540156544
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-02
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 558bfbeb-a479-41e4-a083-bc08323f596a
Device Description
Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dried blood specimens.
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 |
|---|---|---|---|---|
| PJI | Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System | Immunology | 866.5930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59089 | T-cell receptor excision circle (TREC) IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of T-cell receptor excision circles, or circular remnants of deoxyribonucleic acid (DNA) formed during normal T-cell development, in a clinical specimen using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438147331802 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN140010 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -16 Degrees Celsius