FDA UDI
In Commercial Distribution
🇺🇸 United States
Antiserum to Human Prealbumin
DI: B1761540
·
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
- Antiserum to Human Prealbumin
- Primary DI
- B1761540
- Version / Model
- 1
- Catalog Number
- 154002
- 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
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9cc6b24f-4d92-4903-b91d-9ff7a16e7e4a
Device Description
Goat antiserum to Human Prealbumin
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
- 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 |
|---|---|---|---|---|
| JZJ | Prealbumin, Antigen, Antiserum, Control | Immunology | 866.5060 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57532 | Prealbumin (transthyretin) 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 prealbumin (transthyretin) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B1761540 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K850686 | 000 |