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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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Hepatitis B Virus Core Antigen is a purified immunoglobulin fraction of rabbit antiserum that is filtered, sterilized and diluted in buffer pH 7.5, containing BSA and sodium azide as a preservative (analyte specific reagent)
BIO SB, INC.
BSB 5614 (ASR)
In Commercial Distribution

  • B502BSB5614ASR0 ()

  • Total Volume: 0.5 Milliliter
BSB 5614 (ASR)

  • Assay development analyte-specific reagent IVD
Hepatitis B Virus Core Antigen is a purified immunoglobulin fraction of rabbit antiserum that is filtered, sterilized and diluted in buffer pH 7.5, containing BSA and sodium azide as a preservative (analyte specific reagent)
BIO SB, INC.
BSB 5613 (ASR)
In Commercial Distribution

  • B502BSB5613ASR0 ()

  • Total Volume: 0.1 Milliliter
BSB 5613 (ASR)

  • Assay development analyte-specific reagent IVD
The Total IgE ELISA is intended for use in the quantitative determination of immunoglobulin E in human serum. The assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
25-IGEHU-E01
Not in Commercial Distribution

  • B24225IGEHUE010 ()
25-IGEHU-E01

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm.
CS MEDICAL, LLC
202790
In Commercial Distribution

  • B205CS2027901 ()
CS-202790

  • Medical device disinfection solution test strip
The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This unit has a generic USB cable.
Braebon Medical Corporation
MP8
In Commercial Distribution

  • B140MP8U0 ()
MP8

  • Polysomnograph
The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
CERTAIN 3i DIAMETER 5 H 5
Not in Commercial Distribution

  • D821OTEQUATOR030IIC55 ()


  • Dental implant suprastructure, permanent, preformed
The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
CERTAIN 3i DIAMETER 5 H 3
Not in Commercial Distribution

  • D821OTEQUATOR030IIC53 ()


  • Dental implant suprastructure, permanent, preformed
The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
CERTAIN 3i DIAMETER 5 H 2
Not in Commercial Distribution

  • D821OTEQUATOR030IIC52 ()


  • Dental implant suprastructure, permanent, preformed
The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
CERTAIN 3i DIAMETER 5 H 1
Not in Commercial Distribution

  • D821OTEQUATOR030IIC51 ()


  • Dental implant suprastructure, permanent, preformed
The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
CERTAIN 3i DIAMETER 5 H 0,5
Not in Commercial Distribution

  • D821OTEQUATOR030IIC505 ()


  • Dental implant suprastructure, permanent, preformed
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