FDA UDI
In Commercial Distribution
🇺🇸 United States
Anti-panHb APC
DI: 08719327451007
·
Model: IQP-575A
·
IQ Products B.V.
Product Codes
1
GMDN Terms
1
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
- Anti-panHb APC
- Primary DI
- 08719327451007
- Version / Model
- IQP-575A
- Catalog Number
- IQP-575A
- Company Name
- IQ Products B.V.
- Labeler DUNS
- 490578678
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-19
- Public Version
- 1
- Public Version Date
- 2023-07-27
- Public Version Status
- New
- Public Device Record Key
- 73811c10-f421-4518-a8d5-1e1aff99aefe
Device Description
The APC conjugated monoclonal antibody anti-pan Hemoglobin (panHb) antibody recognizes the α-chain of human hemoglobin.
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
- 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 |
|---|---|---|---|---|
| MVU | Reagents, Specific, Analyte | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57270 | Haemoglobin detection IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of haemoglobin in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08719327451007 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius