FDA UDI
In Commercial Distribution
🇺🇸 United States
D-100
DI: 03610522060696
·
Model: 12008984
·
BIO-RAD LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- D-100
- Primary DI
- 03610522060696
- Version / Model
- 12008984
- Catalog Number
- 12008984
- Company Name
- BIO-RAD LABORATORIES, INC.
- Labeler DUNS
- 132528295
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-31
- Public Version
- 1
- Public Version Date
- 2023-02-08
- Public Version Status
- New
- Public Device Record Key
- 59e33849-0720-4a80-9d08-1b18dd65f43e
Device Description
D-100 Hemoglobin Testing System
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
- No
- 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 |
|---|---|---|---|---|
| LDM | INSTRUMENTATION, HIGH PRESSURE LIQUID CHROMATOGRAPHY | Clinical Chemistry | 862.2260 | 1 |
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 | 03610522060696 | GS1 |
Customer Contacts
- Phone
- +1(800)224-6723
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 each |