b8d73fab-ebe6-4aec-93ca-46c87ee56778UpdatePublished22025-03-122022-12-222025-03-11Not in Commercial Distribution00848838024009PrimaryGS1REMELR21620R21620065769564REMEL, INC.1Cary-Blair w/o spoon (15 ml Vial) PK/12 falsefalsefalsefalsefalsefalsetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse62773General specimen collection kit IVD, clinicalA collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.falseActiveLIODevice, Specimen Collectionfalsefalse