FDA UDI
In Commercial Distribution
🇺🇸 United States
Fast 96-Well Background Calibration Plate
DI: 10190302000765
·
Model: 4481308
·
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Fast 96-Well Background Calibration Plate
- Primary DI
- 10190302000765
- Version / Model
- 4481308
- Company Name
- LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
- Labeler DUNS
- 628548377
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 11
- Public Version Date
- 2024-06-04
- Public Version Status
- Update
- Public Device Record Key
- 7e24dde2-54a7-4801-9f97-3b75c6f731fe
Device Description
FAST 96W BACKGND IVD
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OOI | real time Nucleic acid amplification system | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60120 | Nucleic acid hybridization detection IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190302000765 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123955 | 000 |