FDA UDI
In Commercial Distribution
🇺🇸 United States
ELUENT 80A
DI: 04987486015093
·
Model: 103395
·
ARKRAY USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ELUENT 80A
- Primary DI
- 04987486015093
- Version / Model
- 103395
- 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
- 70705331-a1b8-4954-a44a-a50167cf668e
Device Description
These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. These products are used to elute and remove hemoglobin in the column in order of binding strength.
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 |
|---|---|---|---|---|---|---|
| Package | 14987486015090 | GS1 | Carton | 4 | In Commercial Distribution | |
| Primary | 04987486015093 | GS1 |
Customer Contacts
- Phone
- 1-855-646-3108
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162822 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 3 – 30 Degrees Celsius