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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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Declassified as non-medical device. "E-Z ID Rings 200pk Large Jewel System. System includes 200 rings with dispensers and a rack to hold them organized and accessible for use, 2x25 packs of Plum 2x25 packs of Midnight Blue 1x25 pack of Gray 1x25 pack of Teal 1x25 pack of Red 1x25 pack of Copper"
ZIRC DENTAL PRODUCTS, INC.
70Z215
Not in Commercial Distribution

  • 00840161305428 ()


  • Surgical instrument track identification tape
The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids to be used as positive controls to evaluate the performance of the ID CORE XT test(Kit Product Number: 1021720000). The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL 1 and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2, respectively) of the 29 polymorphisms assayed by ID CORE XT. Both control vials must be used in every run of the ID CORE XT test as positive controls for the correct detection of the polymorphism genotypes interrogated by the test. Each control has expected polymorphism genotypes results in the ID CORE XT test when analyzed by the ID CORE XT ANALYSIS SOFTWARE and will produce a valid or invalid run result. ID CORE XT is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in human genomic DNA. ID CORE XT interrogates 29 polymorphisms to predict 53 HEA allele genotypes and 37 antigen phenotypes of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, as an alternative to serology.
PROGENIKA BIOPHARMA, SA
v1
In Commercial Distribution

  • 08437013457040 ()
1301790000

  • Multiple blood group genotyping IVD, control
ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology. The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution

  • 08437013457019 ()
1021720000

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
ID 32 STAPH is a standardized system for the identification of the genera Staphylococcus, Micrococcus and related genera, Rothia and Aerococcus
BIOMERIEUX SA
ID 32 STAPH
In Commercial Distribution

  • 03573026066499 ()
  • 03573026588601 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
Detection in enterobacteria of indole production and the presence of a tryptophan deaminase (TDA). It allows presumptive differentiation of bacteria possessing these characteristics
BIOMERIEUX SA
ID indole TDA
In Commercial Distribution

  • 03573026092443 ()


  • Tryptophan utilization/spot indole microbial reagent IVD
ID 32 C is a standardized system for the identification of yeasts, which uses 32 miniaturized assimilation tests and a database.
BIOMERIEUX SA
32200
In Commercial Distribution

  • 03573026066383 ()


  • Multiple Candida/yeast species culture isolate identification IVD, kit
No Description
Drägerwerk AG & Co. KGaA
MP03377
In Commercial Distribution

  • 04048675545057 ()
  • 04048675545637 ()


  • Ventilator breathing circuit, single-use
No Description
Drägerwerk AG & Co. KGaA
MP03375
In Commercial Distribution

  • 04048675545606 ()
  • 04048675545590 ()


  • Ventilator breathing circuit, single-use
No Description
Drägerwerk AG & Co. KGaA
6872020
In Commercial Distribution

  • 04048675249351 ()
  • 04048675425557 ()


  • Breathing circuit condensate trap, reusable
No Description
Drägerwerk AG & Co. KGaA
MP00340
Not in Commercial Distribution

  • 04048675042310 ()
  • 04048675422143 ()


  • Ventilator breathing circuit, single-use
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