FDA UDI
In Commercial Distribution
🇺🇸 United States
Acrometrix BB NAT HIV-1 POS. CTRL
DI: 00884883005891
·
Model: 963602
·
Microgenics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Acrometrix BB NAT HIV-1 POS. CTRL
- Primary DI
- 00884883005891
- Version / Model
- 963602
- Company Name
- Microgenics Corporation
- Labeler DUNS
- 122153799
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0d4a4991-bf8e-4571-9bc1-cf5bc1ef451c
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| MYZ | Kit,Test(Donors),For Bloodborne Pathogen | Unknown | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48466 | HIV1 nucleic acid 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 human immunodeficiency virus 1 (HIV1) nucleic acid in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884883005891 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK040060 | 0 |