FDA UDI
In Commercial Distribution
🇺🇸 United States
Direct A1c Calibrator Kit
DI: 03661540304293
·
Model: 55120
·
ELITECHGROUP INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Direct A1c Calibrator Kit
- Primary DI
- 03661540304293
- Version / Model
- 55120
- Catalog Number
- 55120
- Company Name
- ELITECHGROUP INC.
- Labeler DUNS
- 052423787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-01
- Public Version
- 1
- Public Version Date
- 2023-10-09
- Public Version Status
- New
- Public Device Record Key
- a29ecf75-0698-43aa-8577-3c2a36d383df
Device Description
Calibrator intended to establish known points of reference for use with Direct A1c Reagent Kit 55370.
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 |
|---|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | Hematology | 864.7470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53315 | Glycated haemoglobin (HbA1c) IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement 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 | 03661540304293 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031539 | 000 |