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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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Biohit Healthcare (Hefei) Co., Ltd.
25 Tests/Kit
In Commercial Distribution

  • 06973774259803 ()
  • 16973774259800 ()
REF:207.01.25.02

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is a lateral flow immunoassay intended for the qualitative detection of and differentiation of IgG and IgM antibodies to SARS-CoV-2 in serum and plasma (dipotassium-EDTA, lithium-heparin, or sodium-citrate). The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicatingrecent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests.
Hangzhou Laihe Biotech Co.,Ltd.
303002
In Commercial Distribution

  • 06972412619405 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804805029 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
CATH PACK, STRL F G
Cardinal Health 200, LLC
SAN68CAT18
In Commercial Distribution

  • 50195594684844 ()
  • 10195594684846 ()
SAN68CAT18

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
BUG, PLZ – Repel & Relief, 12 pcs by Be Smart Get Prepared - (6) Sting Relief Wipes 0.03 oz [0.90 g]; (6) Insect Repellents 0.03 oz [0.90 g]
TOTAL RESOURCES INTERNATIONAL INC.
03COM02032POLYRE; 03OUT02032POLY
In Commercial Distribution

  • 00020424020323 ()
X0044O51AN

  • First aid kit, medicated
Sun Care First Aid Kit, 5 pieces: 2 - Sunscreen Lotion SPF 30 1/8 OZ (3.5 g); 1 - Carrying Case; 2 - Topical Cooling Gel 1/8 OZ (3.5 g)
WAL-MART STORES, INC.
017276235890
Not in Commercial Distribution

  • 20017276235894 ()
  • 00017276235890 ()


  • First aid kit, medicated
Lil' Doc Kid’s First Aid 30 Pieces by Be Smart Get Prepared – (1) SILVEX® Wound Gel 0.18 oz [5 g]; (6) Antiseptic Wipes; (2) Hand Sanitizers 0.05 oz [1.50 g]; (6) Bite Patches 1 sheet; (10) Sheer Bandages 3/4 in x 3 in [1.91 cm x 7.62 cm]; (3) Bamboo Bandages 5/8 in x 2 1/4 in [1.59 cm x 5.72 cm]; (2) Sunscreen Lotions 0.05 oz. [1.50 g]
TOTAL RESOURCES INTERNATIONAL INC.
10HBC01402
In Commercial Distribution

  • 00020424014025 ()


  • First aid kit, medicated
SHH SHOWER SHAVE, HYGIENE CARE 13 pcs – By Be Smart Get Prepared - (1) Toilet Seat Cover Pack 10 pcs; (1) Toilet Paper; (5) Hand Sanitizers 0.05 oz [1.50 g]; (3) Flushable Wet Wipes; (2) Body Wipes 12 in x 12 in [30.48 cm x 30.48 cm]; (1) Shaving Cream 0.25 oz [7.08 g]
TOTAL RESOURCES INTERNATIONAL INC.
10OUT02135
In Commercial Distribution

  • 00020424021351 ()


  • First aid kit, medicated
First Aid Kit, 30 pieces, 2- Hand Sanitizers 1/32 OZ (0.9 G); 24 - 3/4” Crayon Shaped Bandages 0 .75 IN X 2.8 IN (19mm x 71mm); 2- Hand Cleansing Wipes 4 3/4 IN X 7 3/4 IN (12 cm x 19.6 cm); 2- Triple Antibiotic Ointments 1/32 OZ (0.9 G)
Aso LLC
017276237801
In Commercial Distribution

  • 00017276237801 ()
  • 20017276237805 ()
  • 20017276237799 ()


  • First aid kit, medicated
FLYING SOLO - Pre-Travel Essentials - First Aid Kit, 15 pcs By Be Smart, Get Prepared – (5) Hand Sanitizers 0.05 oz [1.50 g]; (4) Antiseptic Wipes; (4) Examination Gloves 2 pairs; (2) Face Masks
TOTAL RESOURCES INTERNATIONAL INC.
10HBC01371; 10HBC01371RECOM
In Commercial Distribution

  • 00020424013714 ()
X0044O8SCL

  • First aid kit, medicated
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