FDA UDI
In Commercial Distribution
🇺🇸 United States
TLiIQ System
DI: 15420045500877
·
Model: TLiIQ System
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TLiIQ System
- Primary DI
- 15420045500877
- Version / Model
- TLiIQ System
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 018925968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-02
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 167868c9-672c-4949-97fb-88dce3a3df9f
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LKV | ENZYME IMMUNOASSAY, FETAL FIBRONECTIN | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57221 | Fibronectin IVD, kit, enzyme immunohistochemistry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of fibronectin in a clinical specimen, using an enzyme immunohistochemistry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045500877 | GS1 | ||||
| Package | 25420045500874 | GS1 | BOX | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P920048 | 006 |