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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count* and WBC count* with Sysmex automated hematology analyzers (*on XS series only).
SYSMEX CORPORATION
98417615
In Commercial Distribution

  • 04987562201402 ()

  • Total Volume: 5 Liter


  • Blood cell lysis reagent IVD
STROMATOLYSER-4DS is to be used to stain the leukocytes in diluted and lysed blood samples for determination of the 4-part differential count with selected Sysmex automated hematology analyzers.
SYSMEX CORPORATION
98417216
In Commercial Distribution

  • 04987562201389 ()

  • Total Volume: 42 Milliliter


  • Blood cell lysis reagent IVD
STROMATOLYSER-IM is lyse reagent for the IMI channel of Sysmex Automated Hematology Analyzers.
SYSMEX CORPORATION
93403213
In Commercial Distribution

  • 04987562200269 ()

  • Total Volume: 10 Liter


  • Blood cell lysis reagent IVD
STROMATOLYSER-FB is a reagent for analyzing basophil counts and WBC counts by the flow cytometry method, using a semiconductor laser.
SYSMEX CORPORATION
94404516
In Commercial Distribution

  • 04987562022335 ()

  • Total Volume: 5 Liter


  • Blood cell lysis reagent IVD
STROMATOLYSER-3WP is a lysing reagent to eliminate red blood cells and cell stroma for use in accurate determination of WBC counts and tri-modal WBC distribution analysis. STROMATOLYSER-3WP is a clear reagent manufactured for use with selected Sysmex Automated Hematology Analyzers.
SYSMEX CORPORATION
85400121
In Commercial Distribution

  • 04987562022090 ()

  • Total Volume: 5 Liter


  • Blood cell lysis reagent IVD
Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.
SEIKAGAKU CORPORATION
00-1111-001-00
In Commercial Distribution

  • 04987541300911 ()
00-1111-001-00

  • Synovial fluid supplementation medium
The device is used to inject fluids into, or withdraw fluids from, the body.
JMS CO., LTD.
551721050
In Commercial Distribution

  • 04987494066261 ()
  • 34987494066262 ()

  • Total Volume: 100 Milliliter


  • General-purpose syringe, single-use
The K-Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter with Pre-Attached Holder is used to access a patient's vein for blood sampling. The device incorporates an integral, active antineedle stick protector.
SB-KAWASUMI LABORATORIES, INC.
DBMH-21G
In Commercial Distribution


  • Needle Gauge: 21 Gauge
DBMH-21G

  • Blood collection set, invasive
The K-Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter with Pre-Attached Holder is used to access a patient's vein for blood sampling. The device incorporates an integral, active antineedle stick protector.
SB-KAWASUMI LABORATORIES, INC.
DBMH-23G
In Commercial Distribution


  • Needle Gauge: 23 Gauge
DBMH-23G

  • Blood collection set, invasive
The K-Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter with Pre-Attached Holder is used to access a patient's vein for blood sampling. The device incorporates an integral, active antineedle stick protector.
SB-KAWASUMI LABORATORIES, INC.
DBMH-25G
In Commercial Distribution


  • Needle Gauge: 25 Gauge
DBMH-25G

  • Blood collection set, invasive
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