FDA UDI
In Commercial Distribution
🇺🇸 United States
OraQuick HCV Rapid Antibody Test
DI: 00608337000535
·
Model: 3001-1521
·
Orasure Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- OraQuick HCV Rapid Antibody Test
- Primary DI
- 00608337000535
- Version / Model
- 3001-1521
- 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
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 29996d94-1b25-4445-92d6-68cdf28141f8
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 |
|---|---|---|---|---|
| MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | Unknown | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30829 | Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total antibodies to the Hepatitis C virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20608337000539 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00608337000535 | GS1 | ||||
| Package | 10608337000532 | GS1 | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- 610-882-1820
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P080027 | 001 |
| P080027 | 003 |
| P080027 | 005 |
| P080027 | 006 |
| P080027 | 007 |
| P080027 | 008 |
| P080027 | 009 |
| P080027 | 010 |
| P080027 | 011 |
| P080027 | 012 |
| P080027 | 013 |
| P080027 | 014 |
| P080027 | 015 |
| P080027 | 016 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius