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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: D122103; MicroScan Dried Gram Neg Non-Fermenter Combo Panel Type 48; MicroScan Dried Gram Negative Combo Panel Type 54; MicroScan Dried Gram Negative BP Combo Panel Type 33; MicroScan Dried Gram Negative BP Combo Panel Type 39; MicroScan Dried Gram Negative BP Combo Panel Type 43; MicroScan Dried Gram Negative BP Combo Panel Type 45; MicroScan Dried Gram Negative BP Combo Panel Type 46; MicroScan Dried Gram Negative BP Combo Type 1E; MicroScan Dried Gram Negative Breakpoint Combo Panel Type 42; MicroScan Dried Gram Negative Combo Panel Type 39; MicroScan Dried Gram Negative Combo Panel Type 53; MicroScan Dried Gram Negative Combo Panel Type 58; MicroScan Dried Gram Negative Fermenter Combo Panel Type 47; MicroScan Dried Gram Negative MIC Panel Type 21; MicroScan Dried Gram Negative MIC Panel Type 34; MicroScan Dried Gram Negative MIC Panel Type 36; MicroScan Dried Gram Negative MIC Panel Type 37; MicroScan Dried Gram Negative MIC Panel Type 39; MicroScan Dried Gram Negative MIC Panel Type 40; MicroScan Dried Gram Negative Urine Combo Panel Type 49; MicroScan Dried Gram Negative Urine Combo Panel Type 52; MicroScan Dried Gram Negative Urine Combo Panel Type 56; MicroScan Dried Gram Negative Urine Combo Panel Type 57; MicroScan Dried Gram Negative Urine Combo Panel Type 59; MicroScan Dried Gram Pos BP Combo 3.2A; MicroScan Dried Gram Pos BP Combo 3.2B; MicroScan Dried Gram Pos BP Combo 3.2J; MicroScan Dried Gram Pos BP Combo Panel Type 3.2A; MicroScan Dried Gram Pos BP Combo Panel Type 3.2A(M); MicroScan Dried Gram Pos BP Combo Panel Type 3.2B; MicroScan Dried Gram Pos BPCombo 3.2J (M); MicroScan Dried Gram Pos Combo 3.2A (M); MicroScan Dried Gram Pos Combo 6.1B; MicroScan Dried Gram Pos Combo 6.1J; MicroScan Dried Gram Pos Combo Panel Type 3.1C; MicroScan Dried Gram Pos Combo Panel Type 3.1J; MicroScan Dried Gram Pos Combo Panely Type 3.1J; MicroScan Dried Gram Pos MIC 3.3J; MicroScan Dried Gram Pos MIC 6.3J; MicroScan Dried Gram Pos Staphylococcus Combo Panel Type 27; MicroScan Dried Gram Pos Streptococcus Combo Panel Type 28; MicroScan Dried Gram Positive BP Combo Panel Type 27; MicroScan Dried Gram Positive BP Combo Panel Type 28; MicroScan Dried Gram Positive BP Combo Panel Type 32; MicroScan Dried Gram Positive BP Combo Panel Type 33; MicroScan Dried Gram Positive Breakpoint Combo Panel Type 29; MicroScan Dried Gram Positive Combo Panel Type 1A; MicroScan Dried Gram Positive Combo Panel Type 31; MicroScan Dried Gram Positive Combo Panel Type 32; MicroScan Dried Gram Positive Combo Panel Type 35; MicroScan Dried Gram Positive Combo Panel Type 36; MicroScan Dried Gram Positive Combo Panel Type 37; MicroScan Dried Gram Positive Combo Panel Type 38; MicroScan Dried Gram Positive MIC Panel Type 25; MicroScan Dried Gram Positive MIC Panel Type 27; MicroScan Dried Gram Positive MIC Panel Type 28; MicroScan Dried Gram Positive MIC Panel Type 31; MicroScan Dried Gram Positive MIC Panel Type 32; MicroScan Dried Gram Positive Staph Combo Panel Type 30; MicroScan MICroFAST 4J; MicroScan MICroFAST 7J; MicroScan MICroSTREP plus Panel Type 2; MicroScan MICroSTREP plus Panel Type 6; MicroScan Neg Bkpt Combo Panel Type 48; MicroScan Neg BP Combo 1J; MicroScan Neg BP Combo 1J (M); MicroScan Neg BP Combo Panel Type 49; MicroScan Neg Combo Panel Type 63; MicroScan Neg Combo Panel Type 66; MicroScan Neg Combo Panel Type 67; MicroScan Neg Combo Panel Type 68; MicroScan Neg Combo Panel Type 72; MicroScan Neg EN Combo 1C; MicroScan Neg EN Combo 1J; MicroScan Neg EN Combo 1T; MicroScan Neg EN MIC 1J; MicroScan Neg Entero Combo Panel Type 70; MicroScan Neg IN Combo 1J; MicroScan Neg MIC 1J; MicroScan Neg MIC Panel Type 42; MicroScan Neg MIC Panel Type 43; MicroScan Neg MIC Panel Type 44; MicroScan Neg NF Combo 1J; MicroScan Neg NF Combo 1T; MicroScan Neg NF Combo 2T; MicroScan Neg Non Entero Combo Panel Type 71; MicroScan Neg OUT Combo 1J; MicroScan Neg Urine Combo Panel Type 69; MicroScan Neg Urine Combo Panel Type 73; MicroScan Neg/Urine Combo Panel Type 64; MicroScan Neg/Urine Combo Panel Type 73; MicroScan Pos Combo 1T; MicroScan Pos Combo Panel Type 39; MicroScan Pos Combo Panel Type 41; MicroScan Pos Combo Panel Type 42; MicroScan Pos MIC Panel Type 33; MicroScan Rapid plus Neg; MicroScan Rapid plus Pos; MicroScan Synergies Plus Negative BP Combo Panel Type 8; MicroScan Synergies Plus Negative Combo Panel Type 3; MicroScan Synergies Plus Negative Urine Combo Panel Type 4; MicroScan Synergies Plus Positive Combo Panel Type 3; MicroScan Synergies Plus Positive MIC Panel Type 2; MICroSTREP Plus Panel Type 3; MICroSTREP Plus Panel Type 5; MircoScan MICroFAST 3J
Classification Name: PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL
Product Code: LTT
Device Class: 2
Regulation Number: 866.1640
Medical Specialty: Microbiology
Registered Establishment Name: Siemens Healthcare Diagnostics Inc.
Registered Establishment Number: 2919016
Owner/Operator: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner/Operator Number: 9096044
Establishment Operations: Manufacturer; U.S. Manufacturer of Export Only Devices
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