FDA.reportPublic FDA data

STRECK LLC

Matched from indexed company URL: Streck, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
19503021950302STRECK LLC1Y2026-01-017002 SOUTH 109TH ST. La Vista NE US 68128
30179531513017953151STRECK LLC1N2026-01-0111710 Peel Circle -- La Vista NE US 68128

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00844509001379CVA - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5.1-800-228-6090custserv@streck.com
00844509001386CVA - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-4, PLT L1-4.1-800-228-6090custserv@streck.com
00844509001393CVA - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-4, WBC L1-4, PLT L1-4.1-800-228-6090custserv@streck.com
00844509001409CVA - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-5, PLT L1-5.1-800-228-6090custserv@streck.com
20844509000314Cal-Chex A Plus - A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 1 vial.1-800-228-6090custserv@streck.com
20844509000338STaK-Chex Plus Retics - A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials of normal level.1-800-228-6090custserv@streck.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
45311775759084K994388XE CHECKGLQ2000-01-14
45311967535935K993825PARA TECH PLUS RETICSJCN1999-11-30
45311833361478K993126CD-CHEX CD 34GGL1999-11-26
45311724065091K992887STAK-CHEX PLUS RETICSGLQ1999-11-22
45311945703921K960894CD-CHEX + RBCGGL1996-05-24
45311080290794K960557CALIBRATION VERIFICATION ASSESSMENT (CVA)JPK1996-04-03
45311920253454K943268SCS-1000 (SYSMEX CALIBRATOR SYSTEM)KSA1994-12-15
45311610471533K933844PARA 4 PLUSJJY1993-12-27
45311309247024K913687CHEM-CHEXJJY1991-09-19
45311159884633K911582STAK-CHEXJCN1991-05-28
45311239156453K905524RETIC-CHEXJPK1991-02-20
45311065026858K901875PARA 12 PLUSJCN1990-05-30
45311888532359K851043SUGAR-CHEX IIJJX1985-04-29
45311014580852K842017PARA 4JPK1984-06-26
45311206033067K840261CAL-CHEX, A HEMATOLOGY CALIBRATORKRZ1984-02-21
45311573467939K823498PARA 12GLQ1982-12-28
45311619576134K231223MDx-Chex for BC-GNPMN2023-07-27
45311020732730K231221MDx-Chex for BC-GPPMN2023-07-27
45311301123061K212576MDx-Chex for BCID2PMN2022-01-19
45311725785821K170091UA-Cellular CompleteJJW2017-02-09
45311993383238K143577XW-100 Automated Hematology Analyzer, XW QC CHECKGKZ2015-10-12
45311308730690K131444UA-CELLULAR COMPLETEJJW2014-01-29
45311556720097K101335CELL-CHEXGLQ2010-08-23
45311961854334K090201UA-CELLULAR FOR IQJPK2009-03-27
45311524693985K090137STAK-CHEX PLUS RETICSGLQ2009-03-18
45311868110553K083200X-CALKRX2009-02-03
45311648580897K080552CYTO-CHEX BCTGIM2008-07-31
2869181648580897K080552CYTO-CHEX BCTGIM2008-07-31
45311551629238K070199RETIC-CHEX LINEARITY FOR BCJPK2007-02-23
45312049410111K063218E-CHECK (XE)JPK2006-12-14
45311676567356K053362CELL-CHEX AUTOJPK2006-01-13
45311926112741K051633CD-CHEX PLUS BCGGL2005-08-16
45311030750062K041240SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYEDNRF2004-06-02
45311818520425K040025A1C-CELLULARJJX2004-03-02
45311715050625K023656SICKLE-CHEX SOLUBILITY KITGHM2002-12-30
45311314706779K020469CAL-CHEX CD PLUSKRX2002-04-04
45311726134558K013316SICKLE-CHEXGHM2001-11-06
45312067350012K000115RETIC CHEX LINEARITYJPK2000-03-27
45311413244947DEN200001Cell-Free DNA BCTQMA2020-08-07
2869181413244947DEN200001Cell-Free DNA BCTQMA2020-08-07
45311005355145
45311043703468
45311344954060
45311377817273
45311551046437
45311551181571
45311736764060
45311741321020
45311877724643
45312059424949
45311017161186
45311036915271
45311080290794
45311137454630
45311145961773
45311166687756
45311201123693
45311206033067
45311219020235
45311314706779
45311322465810
45311326246885
45311394667142
45311424979693
2869181465640808
45311490650020
45311551402084
45311558389383
45311565159075
45311606040269
45311613700697
45311632909127
45311644798774
45311681389028
45311697819472
45311721103951
45311893001821
45311906906801
45311952527203
45311963098471
45311977944462

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JPK82009-03-27
GLQ52010-08-23
PMN32023-07-27
GGL32005-08-16
JCN31999-11-30
QMA22020-08-07
JJW22017-02-09
KRX22009-02-03
GIM22008-07-31
JJX22004-03-02
GHM22002-12-30
JJY21993-12-27
GKZ12015-10-12
NRF12004-06-02
KSA11994-12-15
KRZ11984-02-21

PMN#

101 records. Showing 1-40. Next

GUDID#

MDx-Chex for BC-GN - MDx-Chex™ for BC-GN is intended for use as an external positive and negative assayed control to monitorthe performance of the qualitative detection of Gram-Negative bacteria and associated antimicrobialresistance genes, by the Luminex VERIGENE® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) onLuminex VERIGENE® systems. The MDx-Chex™ for BC-GN Positive and Negative Controls are composedof a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture mediacomponents. Positive Control: Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Klebsiellaoxytoca, Pseudomonas aeruginosa, Species: Acinetobacter spp., Citrobacter spp., Enterobacter spp., Proteusspp.; antimicrobial resistance genes: CTX-M, IMP, KPC, NDM, OXA and VIM. Negative Control: bufferedsolution only. This product is not intended to replace manufacturer controls provided with the device.

STRECK, INC.

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 theperformance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistancegenes, by the Luminex VERIGENE® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on LuminexVERIGENE® systems. The MDx-Chex™ for BC-GP Positive and Negative Controls are composed of a bufferedsolution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components.Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcuslugdunensis, 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 productis not intended to replace manufacturer controls provided with the device.

STRECK, INC.

2023-08-09

189 records. Showing 1-40. Next