FDA UDI
In Commercial Distribution
🇺🇸 United States
Validate
DI: 00859110005708
·
Model: 406bc
·
Lgc Clinical Diagnostics, Inc.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Validate
- Primary DI
- 00859110005708
- Version / Model
- 406bc
- Catalog Number
- 406bc
- Company Name
- Lgc Clinical Diagnostics, Inc.
- Labeler DUNS
- 075886031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-02
- Public Version
- 3
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- c8e4e1f8-e754-41cb-8885-5589aeb3738a
Device Description
Validate PSA is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38182 | Free (unbound) prostate specific antigen (fPSA) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of free (unbound) prostate specific antigen (fPSA) in any of the isoforms [i.e., benign PSA (BPSA), inactive/intact PSA, and/or the PSA precursor, proPSA] in a clinical specimen. | No | Active |
| 38207 | Total prostate specific antigen (tPSA) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859110005708 | GS1 |
Customer Contacts
- Phone
- 1-800-377-9684
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123127 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2 tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -10 Degrees Celsius