FDA UDI
In Commercial Distribution
🇺🇸 United States
OraQuick Advance Rapid HIV 1/2 Antibody Test
DI: 00608337000016
·
Model: 3001-1197
·
Orasure Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- OraQuick Advance Rapid HIV 1/2 Antibody Test
- Primary DI
- 00608337000016
- Version / Model
- 3001-1197
- Company Name
- Orasure Technologies, Inc.
- Labeler DUNS
- 114152184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-05
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d6678785-c442-4d19-bfc7-a95495627ef9
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MTL | Monitor,Test,Hiv-1 | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48454 | HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses and may be available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20608337000010 | GS1 | Carton | 25 | In Commercial Distribution | |
| Primary | 00608337000016 | GS1 | ||||
| Package | 10608337000013 | GS1 | Carton | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- 610-882-1820
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BP010047 | 006 |
| BP010047 | 007 |
| BP010047 | 008 |
| BP010047 | 010 |
| BP010047 | 011 |
| BP010047 | 012 |
| BP010047 | 013 |
| BP010047 | 015 |
| BP010047 | 016 |
| BP010047 | 017 |
| BP010047 | 019 |
| BP010047 | 022 |
| BP010047 | 023 |
| BP010047 | 025 |
| BP010047 | 026 |
| BP010047 | 028 |
| BP010047 | 029 |
| BP010047 | 030 |
| BP010047 | 031 |
| BP010047 | 032 |
| BP010047 | 034 |
| BP010047 | 035 |
| BP010047 | 036 |
| BP010047 | 039 |
| BP010047 | 040 |
| BP010047 | 041 |
| BP010047 | 042 |
| BP010047 | 043 |
| BP010047 | 044 |
| BP010047 | 045 |
| BP010047 | 046 |
| BP010047 | 047 |
| BP010047 | 048 |
| BP010047 | 049 |
| BP010047 | 050 |
| BP010047 | 051 |
| BP010047 | 052 |
| BP010047 | 053 |
| BP010047 | 054 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius