FDA UDI
In Commercial Distribution
🇺🇸 United States
Antiserum to Human Alpha 1 Acid Glycoprotein
DI: B1761230
·
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 Alpha 1 Acid Glycoprotein
- Primary DI
- B1761230
- Version / Model
- 1
- Catalog Number
- 123002
- 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
- 1cdee40b-d2c4-4bcb-bb34-e4ed6b2f5784
Device Description
Goat antiserum to Human Alpha 1 Acid Glycoprotein
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 |
|---|---|---|---|---|
| LKL | Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | Immunology | 866.5420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53607 | Alpha-1-acid glycoprotein (orosomucoid) 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 quantitative measurement of alpha-1-acid glycoprotein (orosomucoid) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B1761230 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K831960 | 000 |