FDA UDI
In Commercial Distribution
🇺🇸 United States
Glycated Hemoglobin (HbA1C) Analyser IVD, 290 Loader, Remanufactured
DI: 00853931008023
·
Model: G8-290SLR
·
TOSOH BIOSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Glycated Hemoglobin (HbA1C) Analyser IVD, 290 Loader, Remanufactured
- Primary DI
- 00853931008023
- Version / Model
- G8-290SLR
- Catalog Number
- 021562R
- Company Name
- TOSOH BIOSCIENCE, INC.
- Labeler DUNS
- 607696440
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-04
- Public Version
- 2
- Public Version Date
- 2018-06-08
- Public Version Status
- Update
- Public Device Record Key
- ff7af318-9d4b-42d1-bb49-4aa915873f6a
Device Description
Glycated hemoglobin (HbA1C) analyzer IVD, 290 Sample Loader, Remanufactured
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 35968 | Glycated haemoglobin (HbA1C) analyser IVD | A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c), also known as glycohaemoglobin, glycosylated haemoglobin or glucosylated haemoglobin, in a clinical specimen. It typically uses a separation technique that is based on charge differences (i.e., ion-exchange chromatography, high pressure liquid chromatography, electrophoresis), chemical analysis (i.e., colorimetry, spectrophotometry), or structural differences (i.e., affinity chromatography and immunoassay). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853931008023 | GS1 |
Customer Contacts
- Phone
- 6143171916
- [email protected]