FDA UDI
In Commercial Distribution
🇺🇸 United States
KOVA
DI: 00855617006743
·
Model: 87176
·
KOVA INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KOVA
- Primary DI
- 00855617006743
- Version / Model
- 87176
- Catalog Number
- 87176
- Company Name
- KOVA INTERNATIONAL, INC.
- Labeler DUNS
- 078780990
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-12
- Public Version
- 1
- Public Version Date
- 2020-08-20
- Public Version Status
- New
- Public Device Record Key
- f8fb9620-3ca2-4446-88cc-a7f8ee91deab
Device Description
LIQUATROL ABNORMAL 2X120ML
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42065 | Urine sediment IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855617006743 | GS1 |
Customer Contacts
- Phone
- 714-902-1700
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius