FDA UDI
In Commercial Distribution
🇺🇸 United States
INTROL CF Panel I Control
DI: 00852720008008
·
Model: v.02
·
Mmqci
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- INTROL CF Panel I Control
- Primary DI
- 00852720008008
- Version / Model
- v.02
- Catalog Number
- G106ac-1
- Company Name
- Mmqci
- Labeler DUNS
- 172874245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-05
- Public Version
- 1
- Public Version Date
- 2019-12-13
- Public Version Status
- New
- Public Device Record Key
- 5034854f-ef3a-4925-ba0b-41f8d1f8cafb
Device Description
This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.
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
- 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 |
|---|---|---|---|---|
| NZB | Quality Control Material, Genetics, Dna | Microbiology | 866.5910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59364 | Cystic fibrosis IVD, control | A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple mutations associated with the inborn genetic disorder cystic fibrosis due to mutation in the cystic fibrosis conductance regulator (CFTR) gene. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852720008008 | GS1 |
Customer Contacts
- Phone
- 207-885-1072
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083171 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Opened material returned to the refrigerator (2° – 8°C) shortly after use is stable for thirty (30) days from the date of opening.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius