OraQuick Advance HIV 1/2 Kit Controls
- Primary DI
- 00608337000009
- Brand
- OraQuick Advance HIV 1/2 Kit Controls
- Company
- Orasure Technologies, Inc.
- Model
- 1001-0077
- Published
- 2014-09-05
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
orasure.comProduct Codes#
| Code | Name |
|---|---|
| MTL | Monitor,Test,Hiv-1 |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MTL | Monitor,Test,Hiv-1 | Unknown | 3 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| 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 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| 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 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00608337000009 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00608337000009 | 00608337000009 | 608337000009 | 0608337000009 |
GMDN Terms#
| Term | Definition |
|---|---|
| HIV1/HIV2 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 antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 610-882-1820 | customercare@orasure.com |
Regulatory Flags#
- DUNS number
- 114152184
- Device count
- 1
- DM exempt
- true
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00608337000115 | OraSure Oral Fluid Collection Device | 3001-2870 | 2019-02-15 | |
| 00608337000559 | Histofreezer | 1001-0375 | 2016-09-15 | |
| 00608337360103 | Histofreezer | 1001-0295 | 2016-09-15 | |
| 00608337365108 | Histofreezer | 1001-0294 | 2016-09-15 | |
| 00608337402100 | Histofreezer | 1001-0293 | 2016-09-15 | |
| 20608337000065 | OraSure Quick Flu 22-Count Flu A + B Kit | 1001-0320 | 2016-11-10 | |
| 00608337000047 | OraSure Quickflu Nasopharyngeal Wash / Aspirate | 1001-0321 | 2016-11-25 | |
| 00608337000054 | OraSure QuickFlu Positive and Negative Control Kit | 1001-0323 | 2018-03-23 | |
| 00608337001297 | Histofreezer | 1001-0336 | 2016-09-16 | |
| 10608337001850 | OraQuick HIV Self-Test | 3001-3822U2 | 2026-05-08 | |
| 00608337001860 | OraQuick HIV Self-Test | 3001-3822UR2 | 2026-05-08 | |
| 00608337000078 | Intercept | 3001-2869 | 2016-07-29 | |
| 00608337150308 | Q.E.D. Saliva Alcohol Test A150 | 60156 | 2016-07-29 | |
| 00608337000030 | Kit, MP Cotinine Serum 100 plate | 1124EC | 2021-01-22 | |
| 00608337000023 | Methamphetamine Intercept 2 Plate Kit | 1104IT | 2016-09-12 | |
| 00608337000085 | Auto-Lyte | 1224UM | 1224UM | 2016-04-29 |
| 00608337000146 | Amphetamine Intercept 5 Plate Kit | 1103IB | 2016-09-12 | |
| 00608337000153 | Amphetamine Intercept 100 Plate Kit | 1103IC | 2016-09-12 | |
| 00608337000184 | Methamphetamine Intercept 5 Plate Kit | 1104IB | 2016-09-12 | |
| 00608337000191 | Methamphetamine Intercept 100 Plate Kit | 1104IC | 2016-09-12 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00817169024880 | 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | MTL | 2023-01-10 |
| 00875197000993 | COBAS AMPLICOR HIV-1 Monitor Test, version 1.5 | Roche Molecular Systems, Inc. | MTL | 2014-09-17 |
| 00608337000016 | OraQuick Advance Rapid HIV 1/2 Antibody Test | Orasure Technologies, Inc. | MTL | 2014-09-05 |
| 20608337000010 | OraQuick Advance Rapid HIV 1/2 Antibody Test | Orasure Technologies, Inc. | MTL | 2014-09-05 |