FDA UDI
In Commercial Distribution
🇺🇸 United States
FOBT-CHEK
DI: 00855574005209
·
Model: OCQP
·
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FOBT-CHEK
- Primary DI
- 00855574005209
- Version / Model
- OCQP
- Company Name
- POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
- Labeler DUNS
- 078413594
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2020-04-06
- Public Version Status
- Update
- Public Device Record Key
- c698a8c4-87c1-4bbf-93a0-efdb41b29612
Device Description
Positive Control for OC-Auto
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
- 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 |
|---|---|---|---|---|
| OOX | Automated Occult Blood Analyzer | Hematology | 864.6550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38218 | Faecal occult blood IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855574005209 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius