FDA UDI
In Commercial Distribution
🇺🇸 United States
DILUENT 80
DI: 04987486015130
·
Model: 103399
·
ARKRAY USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DILUENT 80
- Primary DI
- 04987486015130
- Version / Model
- 103399
- Company Name
- ARKRAY USA, INC.
- Labeler DUNS
- 008171162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-08
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3ae96077-267c-473c-a06a-661f42d3260a
Device Description
These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. This product dilutes commercially available freeze-dried controls and dilutes white blood samples.
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 |
|---|---|---|---|---|
| PDJ | Hemoglobin A1c Test System | Clinical Chemistry | 862.1373 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53316 | Glycated haemoglobin (HbA1c) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987486015130 | GS1 |
Customer Contacts
- Phone
- 1-855-646-3108
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162822 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Opened: Store in a refrigerator (2-8C)
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius