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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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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)
The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to Home Access laboratory for testing.
Home Access Health Corporation
21
In Commercial Distribution

  • M769HIVSTANDARD211 ()


  • Capillary blood collection set, home-use
The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to a qualified laboratory for testing.
Home Access Health Corporation
20
In Commercial Distribution

  • M769HIVEXPRESS201 ()


  • Capillary blood collection set, home-use
No Description
LAMBSMEAD LTD
828457SM
In Commercial Distribution

  • 05060457760242 ()


  • Dermal tissue reconstructive material, animal-derived
24 Volt 2.0Ah SLA
R & D Batteries, Inc.
5717
In Commercial Distribution

  • 00810149092220 ()


  • Portable/mobile rechargeable battery pack
24 Volt 2.5Ah SLA
R & D Batteries, Inc.
5215
In Commercial Distribution

  • 00810149091131 ()


  • Portable/mobile rechargeable battery pack
No Description
BIOTRONIK SE & Co. KG
398789
In Commercial Distribution

  • 04035479135850 ()
398789

  • Cardiac pulse generator analyser cable, single-use
No Description
BIOTRONIK SE & Co. KG
394500
In Commercial Distribution

  • 04035479131609 ()
394500

  • Cardiac pulse generator analyser cable, single-use
ASSY, BATTERY PACK, USA, ZOLL AED 3
Zoll Medical Corporation
1028-000001-30
Not in Commercial Distribution

  • 00847946020958 ()


  • Non-rechargeable professional semi-automated external defibrillator
ASSY, BATTERY PACK, ZOLL AED 3
Zoll Medical Corporation
1028-000001
In Commercial Distribution

  • 00847946020941 ()


  • Non-rechargeable professional semi-automated external defibrillator
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