streck.comMDx-Chex for BCY
Streck, LLC
STRECK LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1950302 | 1950302 | STRECK LLC | 1 | Y | 2026-01-01 | 7002 SOUTH 109TH ST. La Vista NE US 68128 |
| 3017953151 | 3017953151 | STRECK LLC | 1 | N | 2026-01-01 | 11710 Peel Circle -- La Vista NE US 68128 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10844509000089 | CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of Normal level. | 1-800-228-6090 | custserv@streck.com |
| 10844509000096 | CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of CD4L level. | 1-800-228-6090 | custserv@streck.com |
| 30844509000199 | Para 12® Plus - Para 12® Plus is an assayed hematology control for evaluating the accuracy and precision of hematology instruments that provide a white blood cell differential. | 1-800-228-6090 | custserv@streck.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 4531 | 1775759084 | K994388 | XE CHECK | GLQ | 2000-01-14 |
| 4531 | 1967535935 | K993825 | PARA TECH PLUS RETICS | JCN | 1999-11-30 |
| 4531 | 1833361478 | K993126 | CD-CHEX CD 34 | GGL | 1999-11-26 |
| 4531 | 1724065091 | K992887 | STAK-CHEX PLUS RETICS | GLQ | 1999-11-22 |
| 4531 | 1945703921 | K960894 | CD-CHEX + RBC | GGL | 1996-05-24 |
| 4531 | 1080290794 | K960557 | CALIBRATION VERIFICATION ASSESSMENT (CVA) | JPK | 1996-04-03 |
| 4531 | 1920253454 | K943268 | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) | KSA | 1994-12-15 |
| 4531 | 1610471533 | K933844 | PARA 4 PLUS | JJY | 1993-12-27 |
| 4531 | 1309247024 | K913687 | CHEM-CHEX | JJY | 1991-09-19 |
| 4531 | 1159884633 | K911582 | STAK-CHEX | JCN | 1991-05-28 |
| 4531 | 1239156453 | K905524 | RETIC-CHEX | JPK | 1991-02-20 |
| 4531 | 1065026858 | K901875 | PARA 12 PLUS | JCN | 1990-05-30 |
| 4531 | 1888532359 | K851043 | SUGAR-CHEX II | JJX | 1985-04-29 |
| 4531 | 1014580852 | K842017 | PARA 4 | JPK | 1984-06-26 |
| 4531 | 1206033067 | K840261 | CAL-CHEX, A HEMATOLOGY CALIBRATOR | KRZ | 1984-02-21 |
| 4531 | 1573467939 | K823498 | PARA 12 | GLQ | 1982-12-28 |
| 4531 | 1619576134 | K231223 | MDx-Chex for BC-GN | PMN | 2023-07-27 |
| 4531 | 1020732730 | K231221 | MDx-Chex for BC-GP | PMN | 2023-07-27 |
| 4531 | 1301123061 | K212576 | MDx-Chex for BCID2 | PMN | 2022-01-19 |
| 4531 | 1725785821 | K170091 | UA-Cellular Complete | JJW | 2017-02-09 |
| 4531 | 1993383238 | K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECK | GKZ | 2015-10-12 |
| 4531 | 1308730690 | K131444 | UA-CELLULAR COMPLETE | JJW | 2014-01-29 |
| 4531 | 1556720097 | K101335 | CELL-CHEX | GLQ | 2010-08-23 |
| 4531 | 1961854334 | K090201 | UA-CELLULAR FOR IQ | JPK | 2009-03-27 |
| 4531 | 1524693985 | K090137 | STAK-CHEX PLUS RETICS | GLQ | 2009-03-18 |
| 4531 | 1868110553 | K083200 | X-CAL | KRX | 2009-02-03 |
| 4531 | 1648580897 | K080552 | CYTO-CHEX BCT | GIM | 2008-07-31 |
| 286918 | 1648580897 | K080552 | CYTO-CHEX BCT | GIM | 2008-07-31 |
| 4531 | 1551629238 | K070199 | RETIC-CHEX LINEARITY FOR BC | JPK | 2007-02-23 |
| 4531 | 2049410111 | K063218 | E-CHECK (XE) | JPK | 2006-12-14 |
| 4531 | 1676567356 | K053362 | CELL-CHEX AUTO | JPK | 2006-01-13 |
| 4531 | 1926112741 | K051633 | CD-CHEX PLUS BC | GGL | 2005-08-16 |
| 4531 | 1030750062 | K041240 | SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED | NRF | 2004-06-02 |
| 4531 | 1818520425 | K040025 | A1C-CELLULAR | JJX | 2004-03-02 |
| 4531 | 1715050625 | K023656 | SICKLE-CHEX SOLUBILITY KIT | GHM | 2002-12-30 |
| 4531 | 1314706779 | K020469 | CAL-CHEX CD PLUS | KRX | 2002-04-04 |
| 4531 | 1726134558 | K013316 | SICKLE-CHEX | GHM | 2001-11-06 |
| 4531 | 2067350012 | K000115 | RETIC CHEX LINEARITY | JPK | 2000-03-27 |
| 4531 | 1413244947 | DEN200001 | Cell-Free DNA BCT | QMA | 2020-08-07 |
| 286918 | 1413244947 | DEN200001 | Cell-Free DNA BCT | QMA | 2020-08-07 |
| 4531 | 1005355145 | ||||
| 4531 | 1043703468 | ||||
| 4531 | 1344954060 | ||||
| 4531 | 1377817273 | ||||
| 4531 | 1551046437 | ||||
| 4531 | 1551181571 | ||||
| 4531 | 1736764060 | ||||
| 4531 | 1741321020 | ||||
| 4531 | 1877724643 | ||||
| 4531 | 2059424949 | ||||
| 4531 | 1017161186 | ||||
| 4531 | 1036915271 | ||||
| 4531 | 1080290794 | ||||
| 4531 | 1137454630 | ||||
| 4531 | 1145961773 | ||||
| 4531 | 1166687756 | ||||
| 4531 | 1201123693 | ||||
| 4531 | 1206033067 | ||||
| 4531 | 1219020235 | ||||
| 4531 | 1314706779 | ||||
| 4531 | 1322465810 | ||||
| 4531 | 1326246885 | ||||
| 4531 | 1394667142 | ||||
| 4531 | 1424979693 | ||||
| 286918 | 1465640808 | ||||
| 4531 | 1490650020 | ||||
| 4531 | 1551402084 | ||||
| 4531 | 1558389383 | ||||
| 4531 | 1565159075 | ||||
| 4531 | 1606040269 | ||||
| 4531 | 1613700697 | ||||
| 4531 | 1632909127 | ||||
| 4531 | 1644798774 | ||||
| 4531 | 1681389028 | ||||
| 4531 | 1697819472 | ||||
| 4531 | 1721103951 | ||||
| 4531 | 1893001821 | ||||
| 4531 | 1906906801 | ||||
| 4531 | 1952527203 | ||||
| 4531 | 1963098471 | ||||
| 4531 | 1977944462 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JPK | 8 | 2009-03-27 |
| GLQ | 5 | 2010-08-23 |
| PMN | 3 | 2023-07-27 |
| GGL | 3 | 2005-08-16 |
| JCN | 3 | 1999-11-30 |
| QMA | 2 | 2020-08-07 |
| JJW | 2 | 2017-02-09 |
| KRX | 2 | 2009-02-03 |
| GIM | 2 | 2008-07-31 |
| JJX | 2 | 2004-03-02 |
| GHM | 2 | 2002-12-30 |
| JJY | 2 | 1993-12-27 |
| GKZ | 1 | 2015-10-12 |
| NRF | 1 | 2004-06-02 |
| KSA | 1 | 1994-12-15 |
| KRZ | 1 | 1984-02-21 |
PMN#
Cell-Free DNA BCT
Streck, Inc.
MDx-Chex for BC-GP
Streck
MDx-Chex for BC-GN
Streck
MDx-Chex For BCID2
Streck, Inc
UA-Cellular Complete
Streck
XN CAL
Streck
XN CHECK
STRECK
XN CHECK BF
STRECK
XN-L CHECK
STRECK
XN CAL
Streck
XN CAL PF
Streck
XN CHECK
Streck
XN CHECK BF
Streck
UA-CELLULAR COMPLETE
Streck
XN CAL PF
Streck
XN CAL
Streck
XN CHECK
Streck
XN CHECK BF
Streck
CELL-DYN 22 PLUS CALIBRATOR
Streck
CELL-DYN 22 PLUS CONTROL
Streck
CELL-CHEX WITH CPPD CRYSTALS
Streck
CELL-CHEX
Streck
UA-CELLULAR FOR IQ
Streck
STAK-CHEX PLUS RETICS
Streck
CD4 COUNT
Streck
X-CAL
Streck
CYTO-CHEX BCT
Streck
NRBC-CHEX FOR ADVIA
Streck
RETIC-CHEX LINEARITY FOR BC
Streck
E-CHECK (XE)
Streck
NRBC-CHEX FOR LH
Streck
CELL-CHEX AUTO
Streck
IQ BODY FLUIDS CONTROL
Streck
CD-CHEX PLUS BC
Streck
RETIC-CHEX FOR CELL-DYN
STRECK LABORATORIES, INC.
A1C-CELLULAR
STRECK LABORATORIES, INC.
SICKLE-CHEX SOLUBILITY KIT
STRECK LABORATORIES, INC.
CAL-CHEX CD PLUS
STRECK LABORATORIES, INC.
SICKLE-CHEX
STRECK LABORATORIES, INC.
GUDID#
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of Normal level.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of CD4L level.
2016-09-16
MDx-Chex for BC-GN - MDx-Chex™ for BC-GN is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-Negative bacteria and associated antimicrobial resistance genes, by the Luminex VERIGENE® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) on Luminex VERIGENE® systems. The MDx-Chex™ for BC-GN Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa, Species: Acinetobacter spp., Citrobacter spp., Enterobacter spp., Proteus spp.; antimicrobial resistance genes: CTX-M, IMP, KPC, NDM, OXA and VIM. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.
2023-08-09
MDx-Chex for BC-GP - MDx-Chex™ for BC-GP is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes, by the Luminex VERIGENE® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on Luminex VERIGENE® systems. The MDx-Chex™ for BC-GP Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Enterococcus faecium, Streptococcus anginosus group; Species: Staphylococcus spp., Streptococcus spp., Listeria spp.; antimicrobial resistance genes: mecA, vanA and vanB. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.
2023-08-09
Streck Viral Extraction Kit - The Streck® Viral Extraction Kit is intended for use in isolating intact virus particles and associated viral nucleic acids (RNA) contained in clinical samples for use in Molecular Diagnostic Assays. Utilizing Ceres Nanotrap® Microbiome A Particles and Streck developed buffers, viral RNA extraction and purification is completed in less than 30 minutes. Eluted samples can then be utilized for downstream analysis or stored for later use.
2023-06-13
MDx-Chex for BCID2 - MDx-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.
2022-01-25
Para 12® Plus - Para 12® Plus is an assayed hematology control for evaluating the accuracy and precision of hematology instruments that provide a white blood cell differential.
2020-08-24
Cell-Free DNA BCT - Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection, stabilization, and transport of venous whole blood samples for use in conjunction with cell-free DNA next- generation sequencing liquid biopsy assays that have been cleared or approved for use with samples collected in the Cell-Free DNA BCT device.
2020-08-10
Cell-Chex - Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 2 vials each of L1-UC and L2.
2016-09-16
Cell-Chex - Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 6 vials each of L1-UC and L2.
2016-09-16
Para 12 Plus - A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 4 vials each of low, normal and high levels.
2016-09-14
Para 12 Plus - A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 2 vials each of low, normal and high levels.
2016-09-14
Para 12 Plus - A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 1 vial each of low, normal and high levels.
2016-09-14
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial each of levels CD4L and Normal.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials each of levels CD4L and Normal.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials each of levels CD4L and Normal.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials each of levels CD4L and Normal.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials each of levels CD4L and Normal.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial each of levels CD4L and Normal.
2016-09-16
Para 12 Extend - A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of normal level.
2016-09-14
Cyto-Chex BCT - A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 4ml vials.
2017-02-10
Cyto-Chex® BCT - A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 2 ml vials.
2017-08-15
Para 4 - A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contain
2016-09-14
Para 4 - A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contain
2016-09-14
Para 4 - A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contain
2016-09-14
Para 12 Extend - A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of high level.
2016-09-14
Para 12 Extend - A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of low level.
2016-09-14
Para 12 Extend - A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials of normal level.
2016-09-14
CD-Chex Plus BC - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of CD4L level.
2016-09-16
CD-Chex Plus BC - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of Normal level.
2016-09-16
Cal-Chex A Plus - A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 2 vials.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of level CD4L
2016-12-01
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of level Normal
2016-12-01
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 8 vials Normal level.
2016-09-16
Cyto-Chex BCT - A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 4 ml vials.
2016-09-16
STaK-Chex - A whole blood assayed hematology control that offers complete assay values for the 5-part white cell differential available with Beckman Coulter STKS™
2016-09-19
Cyto-Chex® BCT - A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 2 ml vials.
2017-08-15
Cyto-Chex BCT - A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 5 ml vials.
2016-09-16
Para 4 - A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contain
2016-09-14
Para 4 - A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contain
2016-09-14