FDA UDI
In Commercial Distribution
🇺🇸 United States
Rnase P Fast 384-Well Instrument Verification Plate
DI: 10190302000321
·
Model: 4432500
·
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
- Rnase P Fast 384-Well Instrument Verification Plate
- Primary DI
- 10190302000321
- Version / Model
- 4432500
- 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
- 2022-05-01
- Public Version
- 2
- Public Version Date
- 2025-02-06
- Public Version Status
- Update
- Public Device Record Key
- 140cc7bf-6bae-4276-8867-2105938a3aa8
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
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| 61303 | Thermal cycler nucleic acid instrument calibrator/control kit IVD | A collection of reagents and other associated materials of known characteristics intended to be used to calibrate or verify the performance of a thermal cycler nucleic acid instrument/analyser [e.g., real-time polymerase chain reaction (PCR) machine] to ensure its proper function prior to analysis/processing of clinical samples. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190302000321 | GS1 |