FDA UDI
In Commercial Distribution
🇺🇸 United States
ImmunoDOT Borrelia Positive Control
DI: 00613745039053
·
Model: 800-3905
·
Genbio
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ImmunoDOT Borrelia Positive Control
- Primary DI
- 00613745039053
- Version / Model
- 800-3905
- Catalog Number
- 3905
- Company Name
- Genbio
- Labeler DUNS
- 940425333
- 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
- 4b65fffe-3877-45e8-a45a-be61daa38160
Device Description
This serum control contains IgG antibodies specific to Borrelia burgdorferi, the causative agent of Lyme Disease, and is to be used in conjunction with the appropriate ImmunoDOT Assay Test System.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | Microbiology | 866.3830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50562 | Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Borrelia burgdorferi bacteria in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613745039053 | GS1 |
Customer Contacts
- Phone
- 858-592-9300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K911590 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.1 mL |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius