Intercept
GUDID 60608337000070
Intercept Collection Device
Orasure Technologies, Inc.
Oral specimen transport medium collection kit Oral specimen transport medium collection kit Oral specimen transport medium collection kit Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit| Primary Device ID | 60608337000070 |
| NIH Device Record Key | f6f83ab4-34e8-42e3-ba5a-bcdc6dd8cb68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intercept |
| Version Model Number | 3001-2869 |
| Company DUNS | 114152184 |
| Company Name | Orasure Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00608337000078 [Primary] |
| GS1 | 10608337000075 [Package] Contains: 00608337000078 Package: Case [50 Units] In Commercial Distribution |
| GS1 | 20608337000072 [Package] Contains: 00608337000078 Package: Case [500 Units] In Commercial Distribution |
| GS1 | 30608337000079 [Package] Contains: 00608337000078 Package: Bag [10 Units] In Commercial Distribution |
| GS1 | 40608337000076 [Package] Contains: 30608337000079 Package: Case [50 Units] In Commercial Distribution |
| GS1 | 50608337000073 [Package] Contains: 00608337000078 Package: Bag [5 Units] In Commercial Distribution |
| GS1 | 60608337000070 [Package] Contains: 50608337000073 Package: Case [10 Units] In Commercial Distribution |
| GS1 | 70608337000077 [Package] Contains: 00608337000078 Package: Case [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K011057
FDA Product Code
| PJD | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-29 |
Devices Manufactured by Orasure Technologies, Inc.
| 10011822615393 - Rite Aid | 2021-04-07 Precision Freeze Wart Remover System |
| 00608337000030 - Kit, MP Cotinine Serum 100 plate | 2021-02-01 |
| 00608337001433 - OraQuick Ebola Rapid Antigen Test | 2020-03-09 |
| 20608337000119 - OraSure Oral Fluid Collection Device | 2019-03-11 |
| 00608337000863 - OraSure HIV-1 Western Blot Kit | 2018-09-14 |
| 20608337000065 - OraSure Quick Flu 22-Count Flu A + B Kit | 2018-07-06 |
| 00608337000009 - OraQuick Advance HIV 1/2 Kit Controls | 2018-07-06 |
| 20608337000010 - OraQuick Advance Rapid HIV 1/2 Antibody Test | 2018-07-06 |
Trademark Results [Intercept]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTERCEPT 98258796 not registered Live/Pending |
Voxx Electronics Corp. 2023-11-07 |
 INTERCEPT 97594785 not registered Live/Pending |
AURIA SOLUTIONS UK I LTD. 2022-09-16 |
 INTERCEPT 88386153 not registered Live/Pending |
Intercept CX, LLC 2019-04-15 |
 INTERCEPT 88386142 not registered Live/Pending |
Intercept CX, LLC 2019-04-15 |
 INTERCEPT 88051985 not registered Live/Pending |
LI-COR, Inc. 2018-07-25 |
 INTERCEPT 87742219 5657552 Live/Registered |
Hubbell Incorporated 2018-01-03 |
 INTERCEPT 87004494 5082245 Live/Registered |
Youth Villages, Inc 2016-04-18 |
 INTERCEPT 86785314 4968605 Live/Registered |
Positive Proof, Inc. 2015-10-12 |
 INTERCEPT 86740426 5728142 Live/Registered |
Medtronic, Inc. 2015-08-28 |
 INTERCEPT 86691115 not registered Dead/Abandoned |
NCI GROUP, INC. 2015-07-13 |
 INTERCEPT 86467795 5266357 Live/Registered |
INTERCEPT, LLC 2014-12-01 |
 INTERCEPT 86424518 5055185 Live/Registered |
Intercept Pharmaceuticals, Inc. 2014-10-15 |
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