FDA UDI
In Commercial Distribution
🇺🇸 United States
Anti Human complement C5 (b1f) FITC
DI: B1761102
·
Model: 1
·
KENT LABORATORIES INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Anti Human complement C5 (b1f) FITC
- Primary DI
- B1761102
- Version / Model
- 1
- Catalog Number
- 110202
- Company Name
- KENT LABORATORIES INC
- Labeler DUNS
- 093642254
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 2758241b-348a-43cb-a9a9-7c9c98d645b5
Device Description
Fluorescein conjugated polyclonal goat antiserum to Human complement C-5 (b1f)
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 |
|---|---|---|---|---|
| DAY | Complement C5, Antigen, Antiserum, Control | Immunology | 866.5240 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61987 | Complement component C5 IVD, kit, precipitation/immunodiffusion | A collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade component C5 in a clinical specimen, using a precipitation/immunodiffusion method. It is useful in the investigation of conditions associated with C5 deficiency such as lupus erythematosus and recurrent Neiserria infections. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B1761102 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 6 Degrees Celsius