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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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The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
18 test
In Commercial Distribution

  • 08887581000009 ()
0711088018

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.
BIOMERICA, INC.
1009-15
Not in Commercial Distribution

  • 08305901009155 ()


  • Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA)
The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.
BIOMERICA, INC.
1009-15
In Commercial Distribution

  • 00083059100952 ()


  • Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA)
Abbott RealTime IDH2 Amplification Reagent Kit
ABBOTT MOLECULAR INC.
08N82-090
In Commercial Distribution

  • 00884999047044 ()
08N82-090

  • Isocitrate dehydrogenase 2 (IDH2) gene mutation IVD, kit, nucleic acid technique (NAT)
Kelly Retractor 2" x 2 1/2"
Automated Medical Products Corp.
Kelly Retractor 2" x 2 1/2"
In Commercial Distribution

  • 00810118341779 ()
1558 00 SS

  • Surgical retractor/retraction system blade, reusable
Box: 2 varnish, 2 paste, 2 DPA's
YOUNG DENTAL MANUFACTURING I, LLC
295548
In Commercial Distribution

  • 10302732955489 ()


  • Dental coating, tooth-desensitizing
Bag: 2 varnish, 2 paste, 2 DPA's
YOUNG DENTAL MANUFACTURING I, LLC
295335
In Commercial Distribution

  • 10302732953355 ()


  • Dental coating, tooth-desensitizing
Preci-Sagix Female Combination Package 2+2+2
Alphadent NV
1364
In Commercial Distribution

  • 04260576940827 ()

  • Outer Diameter: 2.2 Millimeter
  • female
1364

  • Sliding dental precision attachment
VIPER 2 SYSTEM CASE 2 TRAY 2
DEPUY SPINE, LLC
286705050
In Commercial Distribution

  • 10705034213583 ()
286705050

  • Instrument tray, reusable
2 x 2 x 2 L Plate
OSTEOMED LLC
213-0070
In Commercial Distribution

  • 00845694003353 ()

  • Length: 19 Millimeter
213-0070

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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