FDA UDI
In Commercial Distribution
🇺🇸 United States
SEEKER®
DI: 05430003908563
·
Model: 3416
·
Lacar MDX Technologies
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SEEKER®
- Primary DI
- 05430003908563
- Version / Model
- 3416
- Catalog Number
- 3416
- Company Name
- Lacar MDX Technologies
- Labeler DUNS
- 371365041
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-15
- Public Version
- 1
- Public Version Date
- 2026-01-23
- Public Version Status
- New
- Public Device Record Key
- 7e1ddedc-ea73-4f98-8fae-c13440514be3
Device Description
SEEKER® Quality Control Dried Blood Spot Kit Contains 5 levels: QC Base Pool, QC Low, QC Intermediate, QC Medium, and QC High
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60441 | Newborn metabolic screen/congenital disorder IVD, control | A material which is used to verify the performance of an assay intended to be used in screening a clinical specimen for one or more congenital or metabolic disorders of the newborn. The test typically utilizes whole blood neonate specimens dried on filter paper, and the range of analytes detected may include neonatal thyroxine (neonatal T4), neonatal thyroid stimulating hormone (neonatal TSH), 17-hydroxyprogesterone, immunoreactive trypsinogen, various enzymes and/or amino acids, as indicators of congenital hypothyroidism, adrenal hyperplasia, cystic fibrosis, or other metabolic disorders. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05430003908563 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN150035 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -80 – -70 Degrees Celsius