FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Biomeme DNA/RNA Preservation Buffer (100/pk)
DI: 00810096640109
·
Model: 1
·
Biomeme, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- Biomeme DNA/RNA Preservation Buffer (100/pk)
- Primary DI
- 00810096640109
- Version / Model
- 1
- Catalog Number
- 3000577
- Company Name
- Biomeme, Inc.
- Labeler DUNS
- 079110357
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-12-02
- Public Version
- 2
- Public Version Date
- 2025-08-19
- Public Version Status
- Update
- Public Device Record Key
- eb22a89f-95f7-4c93-8b23-8cbe433176fe
- Distribution End Date
- 2023-08-15
Device Description
Tubes filled with 3mL aliquots of Biomemes DNA/RNA Preservation buffer for sample collection, storage, and preservation at room temperature. Pack of 100 pre-filled tubes.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64747 | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10810096640106 | GS1 | ||||
| Primary | 00810096640109 | GS1 |
Customer Contacts
- Phone
- 2679307707
- [email protected]