FDA UDI
In Commercial Distribution
🇺🇸 United States
D-10 Dual
DI: 00847817003448
·
Model: 220-0210
·
BIO-RAD LABORATORIES, INC.
Product Codes
2
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- D-10 Dual
- Primary DI
- 00847817003448
- Version / Model
- 220-0210
- Catalog Number
- 2200210
- Company Name
- BIO-RAD LABORATORIES, INC.
- Labeler DUNS
- 132528295
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 8
- Public Version Date
- 2023-01-31
- Public Version Status
- Update
- Public Device Record Key
- 468051cb-7442-4ed9-81bc-3deae35205cc
Device Description
D-10 Dual Program Elution Buffer 1
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
- Yes
- 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 |
| JPD | HEMOGLOBIN A2 QUANTITATION | Hematology | 864.7400 | 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 |
| 55883 | Haemoglobin A2 (HbA2) 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 determination of haemoglobin subtype A2 (HbA2) in a clinical specimen. | No | Active |
| 55900 | Haemoglobin F (HbF) 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 determination of haemoglobin subtype F (HbF), also known as foetal haemoglobin, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847817003448 | GS1 |
Customer Contacts
- Phone
- +1(800)224-6723
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041444 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius