FDA UDI
In Commercial Distribution
🇺🇸 United States
4+ Biotinylated Goat Anti-Rabbit IgG (Ms, Rt) Ads
DI: 00847627008336
·
Model: GR608H
·
BIOCARE MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 4+ Biotinylated Goat Anti-Rabbit IgG (Ms, Rt) Ads
- Primary DI
- 00847627008336
- Version / Model
- GR608H
- Company Name
- BIOCARE MEDICAL LLC
- Labeler DUNS
- 806617825
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 2
- Public Version Date
- 2023-07-03
- Public Version Status
- Update
- Public Device Record Key
- f1595554-87d0-4fa3-b8f4-3dbfeb3fc305
Device Description
Alternate name : 4plus Biotinylated Goat Anti-Rabbit IgG (Mouse and rat adsorbed)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | Hematology | 864.1860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57780 | Immunohistochemistry conjugated secondary antibody IVD | One or multiple conjugated immunoglobulins capable of binding to specific antigenic determinants, and intended to be used for the detection of primary antibodies bound to specific cell markers when testing biological tissues or clinical specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847627008336 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius