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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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UTM® - 18053326000482

UTM MINI 1 mL Tube in bulk
COPAN ITALIA SPA
350C
In Commercial Distribution

  • 28053326000489 ()
  • 18053326000482 ()
  • 08053326000485 ()
350C

  • General specimen container IVD, additive/medium

LIM Broth - 18053326000345

TODD HEWITT WITH CNA BROTH FOR AUTOMATION
COPAN ITALIA SPA
476CE.A
In Commercial Distribution

  • 28053326000342 ()
  • 18053326000345 ()
  • 08053326000348 ()
476CE.A

  • General specimen container IVD, additive/medium

LBM® Selenite - 18053326000338

BROTH FOR AUTOMATION 2 mL TUBE
COPAN ITALIA SPA
475CE.A
In Commercial Distribution

  • 28053326000335 ()
  • 18053326000338 ()
  • 08053326000331 ()
475CE.A

  • General specimen container IVD, additive/medium

UTM-RT - 18053326003070

UTM MINI 1ML IN BULK Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimen
COPAN ITALIA SPA
350C.DHI
In Commercial Distribution

  • 28053326003077 ()
  • 18053326003070 ()
  • 08053326003073 ()
350C.DHI

  • General specimen container IVD, additive/medium

UTM® - 18053326002981

UTM 10mL Tube in bulk
COPAN ITALIA SPA
331C
In Commercial Distribution

  • 28053326002988 ()
  • 18053326002981 ()
  • 08053326002984 ()
331C

  • General specimen container IVD, additive/medium

Northeast Laboratory Services - 00810144910987

Todd Hewitt Broth w/ CNA
Northeast Laboratory Services, Inc.
1
In Commercial Distribution

  • 00810144910987 ()
T1865

  • Differential/selective broth culture medium IVD

Northeast Laboratory Services - 00810144910970

Gram Negative (GN) Broth
Northeast Laboratory Services, Inc.
1
In Commercial Distribution

  • 00810144910970 ()
T1470

  • Differential/selective broth culture medium IVD

Northeast Laboratory Services - 00810144910963

Salt Tolerance Broth
Northeast Laboratory Services, Inc.
1
In Commercial Distribution

  • 00810144910963 ()
T1655

  • Differential/selective broth culture medium IVD

Northeast Laboratory Services - 00810144910956

Selenite-Cysteine Broth
Northeast Laboratory Services, Inc.
1
In Commercial Distribution

  • 00810144910956 ()
T1701

  • Differential/selective broth culture medium IVD

Northeast Laboratory Services - 00810144910949

EC Broth w/ Mug
Northeast Laboratory Services, Inc.
1
In Commercial Distribution

  • 00810144910949 ()
T1456

  • Differential/selective broth culture medium IVD

Northeast Laboratory Services - 00810144910932

EC Broth
Northeast Laboratory Services, Inc.
1
In Commercial Distribution

  • 00810144910932 ()
T1455

  • Differential/selective broth culture medium IVD

Northeast Laboratory Services - 00810144910925

Brilliant Green Bile Broth
Northeast Laboratory Services, Inc.
1
In Commercial Distribution

  • 00810144910925 ()
T1172

  • Differential/selective broth culture medium IVD

Northeast Laboratory Services - 00810144910901

MacConkey Broth
Northeast Laboratory Services, Inc.
1
In Commercial Distribution

  • 00810144910901 ()
T1521

  • Differential/selective broth culture medium IVD

Xpert® - 07332940006457

Nasal Sample Collect Kit for Viruses
CEPHEID
SWAB/F-100
In Commercial Distribution

  • 07332940006457 ()
SWAB/F-100

  • General specimen collection kit IVD, clinical

Xpert Nasopharyngeal Sample Collection Kit - 07332940002565

Xpert Nasopharyngeal Sample Collection Kit; 100 pack
CEPHEID
SWAB/B-100
In Commercial Distribution

  • 07332940002565 ()
SWAB/B-100

  • General specimen collection kit IVD, clinical

OneSwab® - 58053326002859

UTM VIRO+2A/PL DAC.BREAK 500 Double plastic applicators polyester tipped
COPAN ITALIA SPA
302CB.MDL
In Commercial Distribution

  • 18053326002851 ()
  • 58053326002859 ()
302CB.MDL

  • General specimen collection kit

PURE ENRICHMENT - B311PEHTNPDS50

Reusable electrode gel pads.
BEAR DOWN CONSULTING
PEHTNPDS5
In Commercial Distribution

  • B311PEHTNPDS51 ()
  • B311PEHTNPDS50 ()
  • B311PEHTNPDS52 ()


  • Transcutaneous electrical stimulation electrode, single-use

PURE ENRICHMENT - B311PEHTNPDS20

Reusable electrode gel pads.
BEAR DOWN CONSULTING
PEHTNPDS2
In Commercial Distribution

  • B311PEHTNPDS21 ()
  • B311PEHTNPDS20 ()
  • B311PEHTNPDS22 ()


  • Transcutaneous electrical stimulation electrode, single-use

PURE ENRICHMENT - B311PETNEMPD5

Wired TENS+EMS+HEAT Replacement Gel Pads
BEAR DOWN CONSULTING
PETNEMPD5
In Commercial Distribution

  • B311PETNEMPD51 ()
  • B311PETNEMPD5 ()
  • B311PETNEMPD52 ()


  • Transcutaneous electrical stimulation electrode, single-use

PURE ENRICHMENT - B311PETNEMPD2

Wired TENS+EMS+HEAT Replacement Gel Pads 2 sets
BEAR DOWN CONSULTING
PETNEMPD2
In Commercial Distribution

  • B311PETNEMPD21 ()
  • B311PETNEMPD2 ()
  • B311PETNEMPD22 ()


  • Transcutaneous electrical stimulation electrode, single-use

N/A - 00816576029075

Tryptic Soy Broth (TSB) with 6.5% Sodium Chloride, 15x45mm Tube without tube label, 1.5ml fill, order by the package of 100 For the differentiation of Enterococci from Group D Streptococci.
HARDY DIAGNOSTICS
D07
Not in Commercial Distribution

  • 00816576020003 ()
  • 00816576029075 ()
D07

  • Differential/selective broth culture medium IVD

VTM-C19 Transit Tube - B08816020

The VTM-C19 Transit Tube contains a viral transport medium (VTM) intended to be inoculated with nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab specimens (Not provided), transported appropriately to the lab and analyzed with validated qRT-PCR assays for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19 disease in humans. Manufacturers Note: Under enforcement discretion, we are currently exempt of having 510(k) during emergency and threat of Covid.
BIO-MED DIAGNOSTICS, INC.
1602
In Commercial Distribution

  • B08816026 ()
  • B08816020 ()
  • B08816021 ()
11-602-001

  • Viral transport medium IVD

InPouch® TV - B08810310

Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.
BIO-MED DIAGNOSTICS, INC.
1031
In Commercial Distribution

  • B08810310 ()
  • B08810317 ()
  • B08810313 ()
21-031-001

  • Differential/selective broth culture medium IVD

BIOER Viral Transport Medium - 06973843228389

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85M1
In Commercial Distribution

  • 06973843228389 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228372

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85S1
In Commercial Distribution

  • 06973843228372 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228365

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-C2
In Commercial Distribution

  • 06973843228365 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228341

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-C
In Commercial Distribution

  • 06973843228341 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228327

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-B1
In Commercial Distribution

  • 06973843228327 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228303

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-A2
In Commercial Distribution

  • 06973843228303 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228297

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-A1
In Commercial Distribution

  • 06973843228297 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228273

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85N1-2
In Commercial Distribution

  • 06973843228273 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228259

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85N1
In Commercial Distribution

  • 06973843228259 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228396

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85L1
In Commercial Distribution

  • 06973843228396 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228358

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-C1
In Commercial Distribution

  • 06973843228358 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228334

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-B2
In Commercial Distribution

  • 06973843228334 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228310

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-B
In Commercial Distribution

  • 06973843228310 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228280

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-A
In Commercial Distribution

  • 06973843228280 ()


  • General specimen container IVD, additive/medium

BIOER Viral Transport Medium - 06973843228266

For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85N1-1
In Commercial Distribution

  • 06973843228266 ()


  • General specimen container IVD, additive/medium

VACUETTE - 19120049209108

Urine CCM / Z Urine No Additive Set with Transfer Device <(>&<)> Towelette consisting of: Item No. 454486 VACUETTE® TUBE 4 ml Urine CCM, 13x75, Round Base Item No. 455028 VACUETTE® TUBE 9 ml Z Urine No Additive, 16x100, Conical Base Item No. 450251 Urine Transfer Device, short Castile Soap Towelette single-packed
Greiner Bio-One GmbH
453044
In Commercial Distribution

  • 29120049209105 ()
  • 19120049209108 ()


  • Evacuated urine specimen container IVD, no additive
  • Evacuated blood collection tube IVD, K3EDTA
  • Urine transfer IVD, sterile

VACUETTE - 19120049209092

Urine CCM Set with Beaker <(>&<)> Towelette consisting of: Item No. 454486 VACUETTE® TUBE 4 ml Urine CCM, 13x75, Round Base Item No. 724310 Urine Beaker with integrated Transfer Device 100 ml Castile Soap Towelette single-packed
Greiner Bio-One GmbH
453043
In Commercial Distribution

  • 29120049209099 ()
  • 19120049209092 ()


  • General specimen container IVD, no additive, sterile
  • Evacuated blood collection tube IVD, K3EDTA
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