FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ReliOn™ Fast A1C Test
DI: 00681131078368
·
Model: 3055
·
WAL-MART STORES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- ReliOn™ Fast A1C Test
- Primary DI
- 00681131078368
- Version / Model
- 3055
- Catalog Number
- 3055
- Company Name
- WAL-MART STORES, INC.
- Labeler DUNS
- 051957769
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2021-10-14
- Public Version Status
- Update
- Public Device Record Key
- f9d905ba-f205-446f-b09b-eb4f137c7a20
- Distribution End Date
- 2018-03-27
Device Description
The ReliOn™ Fast A1C Test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | Hematology | 864.7470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62205 | Glycated haemoglobin (HbA1c) monitoring system IVD, home-use | A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00681131078368 | GS1 | ||||
| Unit of Use | 10681131078365 | GS1 |
Customer Contacts
- Phone
- 1-855-776-0662
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090413 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid running test on hot or cold surfaces or near sources of hot or cold.
- Type
- Special Storage Condition, Specify
- Special Conditions
- If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
- Type
- Special Storage Condition, Specify
- Special Conditions
- If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
- Type
- Storage Environment Temperature
- Temperature Range
- 64 – 77 Degrees Fahrenheit