| Primary Device ID | 00844509002338 |
| NIH Device Record Key | 893839d3-906a-454c-bd9f-12a34988738b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MDx-Chex for BCID2 |
| Version Model Number | 250065 |
| Catalog Number | 250065 |
| Company DUNS | 072915986 |
| Company Name | STRECK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844509002338 [Primary] |
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-02 |
| Device Publish Date | 2022-01-25 |
| 10844509000089 - CD-Chex Plus | 2023-11-20 A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of Normal level. |
| 10844509000096 - CD-Chex Plus | 2023-11-20 A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of CD4L level. |
| 00844509002437 - MDx-Chex for BC-GN | 2023-08-17 MDx-Chex™ for BC-GN is intended for use as an external positive and negative assayed control to monitor the performance of the |
| 00844509002468 - MDx-Chex for BC-GP | 2023-08-17 MDx-Chex™ for BC-GP is intended for use as an external positive and negative assayed control to monitor the performance of the |
| 00844509002376 - Streck Viral Extraction Kit | 2023-06-21 The Streck® Viral Extraction Kit is intended for use in isolating intact virus particles and associated viral nucleic acids (RN |
| 00844509002338 - MDx-Chex for BCID2 | 2022-02-02MDx-Chex for BCID2 is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast, Gram positive and Gram negative bacteria, as well as associated antimicrobial resistance genes, by the BioFire® FilmArray® Blood Culture Identification 2 (BCID2) Panel on FilmArray® systems. Control 1 - GN: Gram negative bacteria: Acinetobacter colcoaceticus-baumannii complex, Bacteroides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenza, Neisseria meningitides, Pseudomonas aeruginosa, Stenotrophomonas maltophilia; antimicrobial resistance genes: KPC, CTX-M, IMP, NDM, OXA-48-like, VIM, mcr-1. Control 2 - GPY: Gram positive bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunesis, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes; yeast: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Cryptococcus neoformans/gatti; antimicrobial resistance genes: mecA/C and MREJ, vanA/B. This product is not intended to replace manufacturer controls provided with the device. |
| 00844509002338 - MDx-Chex for BCID2 | 2022-02-02 MDx-Chex for BCID2 is intended for use as an external positive and negative assayed control to monitor the performance of the qu |
| 30844509000199 - Para 12® Plus | 2020-09-01 Para 12® Plus is an assayed hematology control for evaluating the accuracy and precision of hematology instruments that provide |
| 00844509002253 - Cell-Free DNA BCT | 2020-08-18 Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection, stabilization, and transpor |