FDA UDI
In Commercial Distribution
🇺🇸 United States
QuikCoag Control Level 3 High Abnormal
DI: 00627944000080
·
Model: 1 mL
·
Biomedica Diagnostics Inc
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- QuikCoag Control Level 3 High Abnormal
- Primary DI
- 00627944000080
- Version / Model
- 1 mL
- Company Name
- Biomedica Diagnostics Inc
- Labeler DUNS
- 200152713
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2020-02-24
- Public Version Status
- Update
- Public Device Record Key
- 01836f09-3cd2-4c52-ac17-f93d3862ca35
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 |
|---|---|---|---|---|
| GGN | Plasma, Coagulation Control | Hematology | 864.5425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45787 | Activated partial thromboplastin time (APTT) IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the activated partial thromboplastin time (APTT) of a clinical specimen. | No | Active |
| 55985 | Prothrombin time (PT) IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10627944000087 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00627944000080 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022046 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius