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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 L1-6.
STRECK, INC.
291718
In Commercial Distribution
- 00844509001577 ()
- Total Volume: 3.0 Milliliter
291718
- Full blood count IVD, control
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.
STRECK, INC.
291715
In Commercial Distribution
- 00844509001560 ()
- Total Volume: 3.0 Milliliter
291715
- Full blood count IVD, control
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.
STRECK, INC.
250079
In Commercial Distribution
- 00844509002468 ()
250079
- Multiple-type bloodstream pathogen nucleic acid IVD, control
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.
STRECK, INC.
250080
In Commercial Distribution
- 00844509002437 ()
250080
- Multiple-type bloodstream pathogen nucleic acid IVD, control
Urinalysis control designed specifically for the Sysmex® UF-1000i™ urine analyzer. Contains 1 vial each of Level 1 & 2.
STRECK, INC.
213465
In Commercial Distribution
- 00844509001997 ()
- Total Volume: 45 Milliliter
213465
- Urine sediment IVD, control
Urinalysis control designed specifically for the Iris Diagnostics iQ® automated urine analyzers. Contains 1 vial each of Level 1 & 2.
STRECK, INC.
213396
In Commercial Distribution
- 00844509001966 ()
- Total Volume: 120 Milliliter
213396
- Urine sediment IVD, control
The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. Connection and retention may also be provided by a plastic keeper that is processed into the denture.
STERNGOLD DENTAL LLC
904063
Not in Commercial Distribution
- 00841549110313 ()
- Dental implant suprastructure, permanent, preformed
The SensaTONE for MEN is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
BODY CLOCK HEALTH CARE LIMITED
PF-SENSATONEMEN
In Commercial Distribution
- 05060079211283 ()
- Analgesic transcutaneous electrical nerve stimulation system
MAJ-2011 ATTACHMENT FOR UWIT
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2011
In Commercial Distribution
- 04953170327735 ()
- Portable active medical device mount
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1870
In Commercial Distribution
- 14953170308410 ()
- 04953170308413 ()
- Foot-switch, electrical