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Found 7 results
510(k) Data Aggregation
K Number
K111211Device Name
CELL-DYN 22 PLUS CONTROL
Manufacturer
Streck
Date Cleared
2011-12-22
(237 days)
Product Code
GLQ
Regulation Number
864.8625Why did this record match?
Product Code :
GLQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CELL-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN Emerald 22 system.
Assayed parameters include:
WBC (108/L), RBC (1013L), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), RDW (%), PLT (10°/L), MPV (iL), NEU (%), NEU (10°/L), LYM (%), LYM (10°/L), MON (10°/L), EOS (%),
EOS (10°/L), BAS (%), BAS (10°/L)
Device Description
CELL-DYN 22 Plus Control is an in-vitro diagnostic product that contains stabilized human red blood cells, human, mammalian or simulated white blood cells and a platelet component in a preservative medium. The product is packaged in polypropylene plastic vials containing 2.5ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels (low, normal and high). The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10° C.
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K Number
K110718Device Name
CELL-CHEX WITH CPPD CRYSTALS
Manufacturer
Streck
Date Cleared
2011-05-26
(72 days)
Product Code
GLQ
Regulation Number
864.8625Why did this record match?
Product Code :
GLQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cell-Chex™ with CPPD Crystals is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains calcium pyrophosphate dihydrate (CPPD) Crystals which can be used to monitor the presence of crystals in synovial fluid.
Cell-Chex™ with CPPD Crystals is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear; Neutrophils, Eosinophils, Basophils, Lymphocytes and Monocytes) in body fluid samples performed using Cytospin® smears.
Device Description
Cell-Chex™ with CPPD Crystals is a stabilized suspension of human red blood cells, human white blood cells and calcium pyrophosphate dihydrate (CPPD) Crystals (Level 1 only) in a preservative medium. The product is packaged in glass vials containing 2.0ml. The closures are polypropylene screw caps with polvethylene liners. There are two different levels. Level 1 contains a low cell count and CPPD crystals, and Level 2 contains a high cell count and no crystals. The vials will be packaged in a six (6) or twelve (12) welled vacuum formed clamshell container with the package insert / assay sheet. The product must be stored at 2 - 10°C.
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K Number
K101335Device Name
CELL-CHEX
Manufacturer
Streck
Date Cleared
2010-08-23
(103 days)
Product Code
GLQ, GLO
Regulation Number
864.8625Why did this record match?
Product Code :
GLQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cell-Chex is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains monosodium urate crystals which can be used to monitor the presence of crystals in synovial fluid.
Cell-Chex is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear: Neutrophils, Eosinophils, Basophils, Lymphocytes and Monocytes) in body fluid samples performed using Cytospin® smears.
Device Description
Cell-Chex is a stabilized suspension of human red blood cells, human white blood cells and monosodium urate crystals (Level 1 only) in a preservative medium. The product is packaged in glass vials containing 2.0ml. The closures are polypropylene screw caps with polyethylene liners. There are two different levels. Level 1 contains a low cell count and monosodium urate crystals, and Level 2 contains a high cell count and no crystals. The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10° C.
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K Number
K090137Device Name
STAK-CHEX PLUS RETICS
Manufacturer
Streck
Date Cleared
2009-03-18
(56 days)
Product Code
GLQ
Regulation Number
864.8625Why did this record match?
Product Code :
GLQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
STaK-Chex Plus Retics is an assayed whole blood control for evaluating the accuracy and precision of automated, semi-automated and manual procedures that measure blood cell parameters.
Device Description
STaK-Chex Plus Retics is a stabilized suspension of human red blood cells, a nucleated red blood cell analog, a white blood cell component consisting of human analogs and a platelet component consisting of a non-human analog in a preservative medium. The product is packaged in plastic vials containing 5ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels (low, normal and high). The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10° C.
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K Number
K000945Device Name
PARA 12 PLUS RETICS
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
2000-04-18
(26 days)
Product Code
GLQ
Regulation Number
864.8625Why did this record match?
Product Code :
GLQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994388Device Name
XE CHECK
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
2000-01-14
(17 days)
Product Code
GLQ, GLO, JPK
Regulation Number
864.8625Why did this record match?
Product Code :
GLQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
XE Check is intended to be used as a control for evaluating complete blood cell count (CBC), white cell five-part differential, and reticulocyte percentage on Sysmex XE – 2100 series hematology instruments. The device will consist of three levels: Abnormal Low (characterized by low CBC, high reticulocyte %), Normal (normal CBC, normal reticulocyte %), and Abnormal High (high CBC, low reticulocyte %).
Device Description
XE Check is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.6 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
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K Number
K992887Device Name
STAK-CHEX PLUS RETICS
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
1999-11-22
(87 days)
Product Code
GLQ
Regulation Number
864.8625Why did this record match?
Product Code :
GLQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
STaK-Chex Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Beckman/Coulter GenS series hematology instruments.
Device Description
STaK-Chex Plus Retics is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.5 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
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