FDA UDI
In Commercial Distribution
🇺🇸 United States
LeadCare® II Blood Lead Testing System 9X ClinicalTest Kit
DI: 00850355006109
·
Model: LeadCare® II
·
MAGELLAN DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LeadCare® II Blood Lead Testing System 9X ClinicalTest Kit
- Primary DI
- 00850355006109
- Version / Model
- LeadCare® II
- Catalog Number
- 80-0161
- Company Name
- MAGELLAN DIAGNOSTICS, INC.
- Labeler DUNS
- 078525694
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 5480ca8e-4e4b-43dd-a9b9-284d9b817cfe
Device Description
LeadCare® II Blood Lead Testing System 9X ClinicalTest Kit
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| DOF | Lead, Atomic Absorption | Clinical Toxicology | 862.3550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31646 | Lead (Pb) analyser IVD | An electrically-powered laboratory instrument intended to be used for the quantitative determination of the heavy metal lead (Pb) in a clinical specimen, using technology which may incorporate fluorometry or electrometry. The analyser requires the use of specific reagents and test strips, packaged together in a test kit. The analyser is intended to be used by health professionals at the point-of-care, and often also in the laboratory. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850355006109 | GS1 |
Customer Contacts
- Phone
- 800-275-0102
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052549 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep sensors sealed in their container until the sample is prepared and you are ready to perform the test. The container is lined with desiccant to keep the sensors fresh.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from direct sunlight.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place. Do NOT freeze or refrigerate.
- Type
- Storage Environment Temperature
- Temperature Range
- 60 – 80 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 60 – 80 Degrees Fahrenheit