FDA UDI
In Commercial Distribution
🇺🇸 United States
Borrelia B31 ViraChip® IgM Test Kit
DI: EVIRBBCMOK1
·
Model: V-BBCMOK
·
Viramed Biotech AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Borrelia B31 ViraChip® IgM Test Kit
- Primary DI
- EVIRBBCMOK1
- Version / Model
- V-BBCMOK
- Catalog Number
- V-BBCMOK
- Company Name
- Viramed Biotech AG
- Labeler DUNS
- 329748847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-08
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 42a8be92-17cc-4b61-af8c-6ff7da60dee8
Device Description
Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 in human serum.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| 50555 | Borrelia burgdorferi total antibody IVD, kit, immunoblot | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Borrelia burgdorferi in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EVIRBBCMOK1 | HIBCC |
Customer Contacts
- Phone
- +4989899336
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163695 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 96 tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius