InActiv Blue
InActiv Blue is a collection and transport medium for upper respiratory specimens suspected of containing SARS-CoV-2. It inactivates virus and stabilizes RNA so the collected material can…
InActiv Blue is a collection and transport medium for upper respiratory specimens suspected of containing SARS-CoV-2. It inactivates virus and stabilizes RNA so the collected material can be used with a legally marketed molecular diagnostic test.
The solution contains guanidine thiocyanate, N-lauroylsarcosine and EDTA. These ingredients disrupt viral structures and inhibit enzymes that degrade RNA. The medium preserves SARS-CoV-2 RNA for seven days at refrigerated temperatures of 2 to 8 degrees Celsius or ambient temperatures of 20 to 25 degrees Celsius.
Listed Item
InActiv Blue is a pathogen-inactivating and DNA/RNA stabilizing medium used for transport of naso- or oropharyngeal swabs, or saliva sampled from patients for in vitro diagnostic testing on the presence of genetic material of a virus by RT-qPCR or other molecular method (SARS-CoV-2, Influenza A/B, RSV A/B).
Collection Tube
IB_TUB contains two millilitres of medium in a polypropylene tube with a high-density polyethylene cap. It is supplied non-sterile for single use, without a swab.
Who Else Makes It
Concentrated in Zhejiang (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Hangzhou Bioer Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
Record
| Listed by | Fertipro NV, Belgium |
|---|---|
| FDA product code | QBD |
| Device type | Microbial Nucleic Acid Storage And Stabilization Device |
| Device class | Class 2 |
| Regulation | 21 CFR 866.2950 |
| 510(k) | K221547 |
| Record published | 2024-08-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Rack of 50, carboard box of 400, carboard box of 1200 |
| Sizes | Total volume 2 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IB_TUB | Total Volume 2 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dakewe | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 12 |
| PrimeStore MTM | Longhorn Vaccines and Diagnostics LLC | 10 |
| PurSafe+ | Puritan Medical Products Company LLC | 4 |
| Magbio Genomics, Inc. | Magbio Genomics Inc. | 3 |
| eNAT® | Copan Italia | 3 |
| BioSci™ | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 3 |
| Dtpm | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 2 |
| Zhejiang Gene Science | Zhejiang Gene Science Co., Ltd. | 2 |
| Xpert Swab Specimen Collection Kit | Cepheid | 1 |
| Bioer Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. | 1 |
| BioMAX | Spectrum Solutions L.L.C. | 1 |
| Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. | 1 |
Showing 12 of 14. All products under Microbial Nucleic Acid Storage And Stabilization Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221547 | 2024-06-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.