FDA UDI
In Commercial Distribution
🇺🇸 United States
VALIDATE
DI: 00850011135679
·
Model: 503re
·
Lgc Clinical Diagnostics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VALIDATE
- Primary DI
- 00850011135679
- Version / Model
- 503re
- Company Name
- Lgc Clinical Diagnostics, Inc.
- Labeler DUNS
- 075886031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-15
- Public Version
- 2
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- 593eff7c-c274-4d53-97fa-0a207d4ec8e9
Device Description
VALIDATE Fertility 4 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analyte: Placental growth factor (PlGF). VALIDATE Test Kits are non-automated and intended for laboratory professional use only. Each test kit consists of one bottle each of Levels 1 through 5. Each bottle contains 4.0 milliliters. There exists a linear relationship among Levels 1 through 5 for each set.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56615 | Placental growth factor (PLGF) IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of placental growth factor (PLGF) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011135679 | GS1 |
Customer Contacts
- Phone
- 1-800-377-9684
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -10 Degrees Celsius