DEVICE: ORAcollect Dx (00627595000309)
Device Identifier (DI) Information
ORAcollect Dx
OCD-100
In Commercial Distribution
DNA Genotek Inc
OCD-100
In Commercial Distribution
DNA Genotek Inc
DNA Specimen Collection, Saliva
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| Yes | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 61935 | Specimen stabilization reagent IVD |
A substance or reactant intended to be used alone or in combination with other IVDs to prevent degradation of sensitive analytes (e.g., hormones, proteins, peptides and/or nucleic acids) in a clinical specimen during transportation, storage or processing. A stabilizer is typically a solvent, antioxidant or an enzyme inhibitor.
|
Active | false |
| 57940 | Oral/upper respiratory tract specimen collection swab |
A piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for culture, analysis, and/or other investigation. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| OYJ | Dna Specimen Collection, Saliva |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit |
| Storage Environment Temperature: between 15 and 25 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
4f3538d2-4ec0-427c-bbc9-39172bff38e2
August 13, 2024
10
September 10, 2016
August 13, 2024
10
September 10, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 10627595000306 | 25 | 00627595000309 | In Commercial Distribution | Reclosable Bag | |
| 00627595001108 | 1 | 00627595000309 | In Commercial Distribution | OCD-100.008 | |
| 10627595001112 | 25 | 00627595001108 | In Commercial Distribution | OCD-100.008+ACP096 | |
| 10627595000078 | 10 | 00627595000309 | In Commercial Distribution | OCD-100+ACP041 | |
| 00627595000040 | 1 | 00627595000309 | In Commercial Distribution | OCD-100.032 | |
| 10627595000047 | 25 | 00627595000040 | In Commercial Distribution | OCD-100.032 Reclobag | |
| 00627595000163 | 25 | 00627595000040 | In Commercial Distribution | OCD-100.032+ACP103 | |
| 00627595001085 | 1 | 00627595000309 | In Commercial Distribution | OCD-100.033 | |
| 00627595000057 | 1 | 00627595000309 | In Commercial Distribution | OCD-100.034 | |
| 00627595000170 | 25 | 00627595000309 | In Commercial Distribution | OCD-100.034+ACP099 | |
| 10627595000955 | 25 | 00627595000309 | In Commercial Distribution | OCD-100+ACP127 | |
| 10627595000863 | 1 | 00627595000309 | In Commercial Distribution | OCD-100+ACP126 | |
| 00627595000835 | 1 | 00627595000309 | In Commercial Distribution | OCD-100.035 | |
| 10627595000832 | 10 | 00627595000835 | In Commercial Distribution | OCD-100.035+ACP140 | |
| 10627595001327 | 25 | 00627595000309 | 2024-01-01 | Not in Commercial Distribution | OCD-100+ACP125 |
| 10627595000856 | 1 | 00627595000309 | In Commercial Distribution | SOF-1015 | |
| 10627595001365 | 1 | 00627595000309 | 2023-12-01 | Not in Commercial Distribution | SOF-1017 |
| 10627595000993 | 1 | 00627595000309 | In Commercial Distribution | SOF-4814 | |
| 10627595001372 | 1 | 00627595000309 | 2024-01-01 | Not in Commercial Distribution | SOF-1018 |
| 10627595001099 | 1 | 00627595000309 | In Commercial Distribution | SOF-1011 | |
| 00627595001146 | 1 | 00627595000309 | In Commercial Distribution | OCD-100.037 | |
| 10627595001150 | 25 | 00627595000309 | In Commercial Distribution | OCD-100.037+ACP152 |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-866-813-6354
info@dnagenotek.com
info@dnagenotek.com