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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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N/A - 00819398023818

Viral Transport Medium VTM, 3ml fill (swabs sold separately), order by the package of 20 Hardy Diagnostics Viral Transport Medium is recommended for the collection and transport of clinical specimens for the preservation of viral agents including, Influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory.
HARDY DIAGNOSTICS
R99
In Commercial Distribution

  • 00819398023801 ()
  • 00819398023818 ()
R99

  • Microbiological transport medium IVD

N/A - 00819398023610

GN Broth, 12x80mm tube, 4ml fill, order by the package of 100 For the selective enrichment of Salmonella and Shigella spp. in stool specimens.
HARDY DIAGNOSTICS
R76BX
In Commercial Distribution

  • 00819398023603 ()
  • 00819398023610 ()
R76BX

  • Differential/selective broth culture medium IVD

N/A - 00819398022859

SIM (Sulfide, Indole, Motility) Medium, 8ml, 16x100mm tube, order by the package of 20 (Sulfide-Indole-Motility) For the identification of gram negative bacilli based on sulfide production, indole formation, and motility.
HARDY DIAGNOSTICS
Q30
In Commercial Distribution

  • 00819398022842 ()
  • 00819398022859 ()
Q30

  • Differential/selective broth culture medium IVD

N/A - 00819398022439

LIM Broth, 5mL, 16x100mm skirted PP tube, 100 tubes/box For the selective enrichment of group B streptococci (Streptococcus agalactiae). Especially for anovaginal specimens from pregnant women. Compatible with automated inoculation systems.
HARDY DIAGNOSTICS
L59
Not in Commercial Distribution

  • 00819398022422 ()
  • 00819398022439 ()
L59

  • Differential/selective broth culture medium IVD

N/A - 00819398022415

LIM Broth, for Group B Strep, 5ml fill, 15x103mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 LIM Broth is recommended for the selective enrichment of group B streptococci (Streptococcus agalactiae) from anovaginal specimens from pregnant women
HARDY DIAGNOSTICS
L57
In Commercial Distribution

  • 00819398022408 ()
  • 00819398022415 ()
L57

  • Differential/selective broth culture medium IVD

N/A - 00819398021234

BHI with CIPRO 10µg/mL, 5mL, 15x103mm tube, 20 tubes/pack (Brain Heart Infusion Broth wtih ciprofloxacin, 10µg/mL) For use as a pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.
HARDY DIAGNOSTICS
K255
In Commercial Distribution

  • 00819398021227 ()
  • 00819398021234 ()
K258

  • Differential/selective broth culture medium IVD

N/A - 00819398021098

Acanthamoeba Broth, 15x103mm Tube, 5ml. Hardy Diagnostics Acanthamoeba Broth, also known as Peptone-Yeast Extract-Glucose (PYG) Medium, is recommended for the maintenance of Acanthamoeba stock cultures.
HARDY DIAGNOSTICS
K225
In Commercial Distribution

  • 00819398021081 ()
  • 00819398021098 ()
K225

  • Differential/selective broth culture medium IVD

N/A - 00819398021012

MacConkey Broth, 10mL, 16x125mm tube, 20 tubes/box For the detection of gram-negative, lactose fermenting bacilli. Contains a durham tube for gas detection.
HARDY DIAGNOSTICS
K194
In Commercial Distribution

  • 00819398021005 ()
  • 00819398021012 ()
K194

  • Differential/selective broth culture medium IVD

N/A - 00819398020756

Tryptic Soy Broth (TSB) with 6.5% Sodium Chloride, 15x103mm Tube, 5ml. Hardy Diagnostics Tryptic Soy Broth (TSB) with 6.5% NaCl is a growth medium recommended for the differentiation of enterococci from the group D streptococci. This medium is also useful as an enrichment step for increasing sensitivity in the detection of MRSA in high risk patients.
HARDY DIAGNOSTICS
K126
In Commercial Distribution

  • 00819398020749 ()
  • 00819398020756 ()
K126

  • Differential/selective broth culture medium IVD

N/A - 00819398020671

Bile Esculin Azide Broth, 15x103mm Tube, 5ml. Hardy Diagnostics Bile Esculin with Azide Media are recommended for the isolation and differentiation of group D streptococci from non-group D streptococci.
HARDY DIAGNOSTICS
K11
In Commercial Distribution

  • 00819398020664 ()
  • 00819398020671 ()
K11

  • Differential/selective broth culture medium IVD

N/A - 00819398020619

Modified Diamonds Medium, 16x100mm Tube, 6ml. Hardy Diagnostics Modified Diamonds Medium is recommended as an enriched and selective medium for the isolation and cultivation of Trichomonas species from clinical specimens, especially T. vaginalis.
HARDY DIAGNOSTICS
K02
Not in Commercial Distribution

  • 00819398020602 ()
  • 00819398020619 ()
K02

  • Differential/selective broth culture medium IVD

N/A - 00819398020596

GN Broth, 15x103mm Tube, 6ml. Hardy Diagnostics GN (Gram-Negative) Broth is recommended for the selective enrichment of Shigella and Salmonella spp. in clinical and non-clinical specimens.
HARDY DIAGNOSTICS
K01
In Commercial Distribution

  • 00819398020589 ()
  • 00819398020596 ()
K01

  • Differential/selective broth culture medium IVD

PCRopsis - B550888100158

PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory. PCRopsis™ UVT (1.5 mL) is aliquoted into 100x sterile, 10 mL transport tubes.
ENTOPSIS, LLC
Universal Viral Transport (100x 1.5 mL)
Not in Commercial Distribution

  • B550888100158 ()
  • B55088800015 ()
88810015

  • Viral transport medium IVD

PCRopsis - B550888100038

PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory. PCRopsis™ UVT (3 mL) is aliquoted into 100x sterile, 10 mL transport tubes.
ENTOPSIS, LLC
Universal Viral Transport (100x 3 mL)
Not in Commercial Distribution

  • B55088800003 ()
  • B550888100038 ()
88810003

  • Viral transport medium IVD

PCRopsis - B5508880200

PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.
ENTOPSIS, LLC
Universal Viral Transport
Not in Commercial Distribution

  • B5508880200 ()
888020

  • Viral transport medium IVD

PCRopsis - B5508880050

PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.
ENTOPSIS, LLC
Universal Viral Transport
Not in Commercial Distribution

  • B5508880050 ()
888005

  • Viral transport medium IVD

PCRopsis - B5508880010

PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.
ENTOPSIS, LLC
Universal Viral Transport
Not in Commercial Distribution

  • B5508880010 ()
888001

  • Viral transport medium IVD

Tissue-Tek® - 10615233078657

O.C.T. Compound
SAKURA FINETEK U.S.A., INC.
4583
In Commercial Distribution

  • 10615233078657 ()
  • 00615233078650 ()
4583

  • Tissue freezing/embedding medium IVD

Alpha-Tec Systems - 00816085024127

VTM Viral Transport Medium Pack
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024127 ()
0003730

  • Sputum specimen liquefaction/decontamination kit IVD

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

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

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

N/A - 00816576026883

Auris Enrichment Broth, Fill 2mL (Sabouraud Salt Dulcitol Broth with Chloramphenicol & Gentamicin) For the selective enrichment of Candida auris from patient and environmental samples
HARDY DIAGNOSTICS
R12
In Commercial Distribution

  • 00816576026876 ()
  • 00816576026883 ()
R12

  • Differential/selective broth culture medium IVD

N/A - 00816576026708

SIM (Sulfide, Indole, Motility) Medium, 6ml, 16x125mm tube, order by the package of 10 (Sulfide-Indole-Motility) For the identification of gram negative bacilli based on sulfide production, indole formation, and motility.
HARDY DIAGNOSTICS
7025
Not in Commercial Distribution

  • 00816576026692 ()
  • 00816576026708 ()
7025

  • Differential/selective broth culture medium IVD

TransPRO - 00816576026067

TransPRO Viral Transport Medium System, single 16x100mm polypropylene tube, 3ml fill with individually wrapped, sterile, mini-tip, flocked swab with 80mm breakpoint. Hardy Diagnostics’ Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents including, Influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory.
HARDY DIAGNOSTICS
TPV50
In Commercial Distribution

  • 00816576025800 ()
  • 00816576026067 ()
TPV50

  • Microbiological transport 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

Urine Monovette® 10ml bor.acid - 04038917279918

No Description
Sarstedt Aktiengesellschaft & Co.KG
10.253
In Commercial Distribution

  • 04038917163354 ()
  • 04038917279918 ()
10.253

  • Non-evacuated urine specimen container IVD, preservative

V-Monovette®Urine 10ml bo.acid - 04038917263429

No Description
Sarstedt Aktiengesellschaft & Co.KG
11.2453.001
In Commercial Distribution

  • 04038917263436 ()
  • 04038917263429 ()
11.2453.001

  • Evacuated urine specimen container IVD, preservative

V-Monovette® Urine 4ml bo.acid - 04038917245128

No Description
Sarstedt Aktiengesellschaft & Co.KG
11.2253.001
In Commercial Distribution

  • 04038917245135 ()
  • 04038917245128 ()
11.2253.001

  • Evacuated urine specimen container IVD, preservative

Urine Monovette® 10ml bor.acid - 04038917104548

No Description
Sarstedt Aktiengesellschaft & Co.KG
10.253.020
In Commercial Distribution

  • 04038917183147 ()
  • 04038917104548 ()
10.253.020

  • Non-evacuated urine specimen container IVD, preservative

Starswab Multitrans System - 00840165400587

No Description
Pretium Canada Packaging ULC
S160-URETH
In Commercial Distribution

  • 00840165400594 ()
  • 00840165400587 ()
  • 10840165400584 ()


  • General specimen collection kit IVD, clinical

Starswab Multitrans System - 00840165400563

Starswab Multitrans System with minitip flocked swab applicator and 1 ml media fill.
Pretium Canada Packaging ULC
S160-NASO-1
In Commercial Distribution

  • 00840165400570 ()
  • 00840165400563 ()
  • 10840165400560 ()


  • General specimen collection kit IVD, clinical

Starswab Multitrans System - 00840165400549

Starswab Multitrans System with minitip flocked swab applicator.
Pretium Canada Packaging ULC
S160-NASO
In Commercial Distribution

  • 00840165400556 ()
  • 00840165400549 ()
  • 10840165400546 ()


  • General specimen collection kit IVD, clinical

Starswab Multitrans System - 00840165400525

Starswab Multitrans System with one standard nylon flocked swab and one minitip nylon flocked swab.
Pretium Canada Packaging ULC
S160-FL-COM
In Commercial Distribution

  • 00840165400532 ()
  • 00840165400525 ()
  • 10840165400522 ()


  • General specimen collection kit IVD, clinical

Starswab Multitrans System - 00840165400501

Starswab Multitrans System with standard nylon flocked swab applicator.
Pretium Canada Packaging ULC
S160-FL
In Commercial Distribution

  • 00840165400518 ()
  • 00840165400501 ()
  • 10840165400508 ()


  • General specimen collection kit IVD, clinical

Starswab Multitrans System - 00840165400488

Starswab Multitrans System with standard plastic shaft polyester tip swab applicator.
Pretium Canada Packaging ULC
S160-100
In Commercial Distribution

  • 00840165400495 ()
  • 00840165400488 ()
  • 10840165400485 ()


  • General specimen collection kit IVD, clinical

Starswab Multitrans System - 00840165400464

No Description
Pretium Canada Packaging ULC
S160-0
In Commercial Distribution

  • 00840165400471 ()
  • 00840165400464 ()
  • 10840165400461 ()


  • General specimen collection kit IVD, clinical

Starswab Anaerobic Transport System - 00840165400440

Starswab Anaerobic Transport System, 5 ml Media Fill, Double Plastic Shaft Rayon Tip Swab Applicator.
Pretium Canada Packaging ULC
S120-5
In Commercial Distribution

  • 00840165400457 ()
  • 00840165400440 ()
  • 10840165400447 ()


  • General specimen collection kit IVD, clinical

Starswab Anaerobic Transport System - 00840165400426

Starswab Anaerobic Transport System, 7 ml media fill, double plastic shaft rayon tip swab applicator.
Pretium Canada Packaging ULC
S120-D
In Commercial Distribution

  • 00840165400433 ()
  • 00840165400426 ()
  • 10840165400423 ()


  • General specimen collection kit IVD, clinical

Starswab Anaerobic Transport System - 00840165400402

Starswab Anaerobic Transport System Media Tube Only, No Swab Applicator.
Pretium Canada Packaging ULC
S120-0
In Commercial Distribution

  • 00840165400419 ()
  • 00840165400402 ()
  • 10840165400409 ()


  • General specimen collection kit IVD, clinical

Starswab II Bacteriology Culture Collection and Transport System - 00840165400280

Starswab II Bacteriology Culture Collection and Transport System with Liquid Stuart medium and standard plastic shaft nylon flocked swab.
Pretium Canada Packaging ULC
SP132-FL
In Commercial Distribution

  • 00840165400297 ()
  • 00840165400280 ()
  • 10840165400287 ()


  • General specimen collection kit IVD, clinical

Starswab II Bacteriology Culture Collection and Transport System - 00840165400266

Starswab II Bacteriology Culture Collection and Transport System with Liquid Stuart medium and wire shaft rayon tip swab applicator.
Pretium Canada Packaging ULC
SP132-W
In Commercial Distribution

  • 00840165400273 ()
  • 00840165400266 ()
  • 10840165400263 ()


  • General specimen collection kit IVD, clinical

Starswab II Bacteriology Culture Collection and Transport System - 00840165400242

Starswab II Bacteriology Culture Collection and Transport System with Liquid Stuart medium and double plastic shaft rayon tip swab applicators.
Pretium Canada Packaging ULC
SP132D
In Commercial Distribution

  • 00840165400259 ()
  • 00840165400242 ()
  • 10840165400249 ()


  • General specimen collection kit IVD, clinical

Starswab II Bacteriology Culture Collection and Transport System - 00840165400228

Starswab II Bacteriology Culture Collection and Transport System with Liquid Stuart medium and single plastic shaft rayon tip swab applicator.
Pretium Canada Packaging ULC
SP132
In Commercial Distribution

  • 00840165400235 ()
  • 00840165400228 ()
  • 10840165400225 ()


  • General specimen collection kit IVD, clinical

EDGE BIOLOGICALS INC - B645T2255

CHOPPED MEAT MEDIUM
EDGE BIOLOGICALS, INC.
T2255
Not in Commercial Distribution

  • B645T22551 ()
  • B645T2255 ()


  • Enriched broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0781

STAPH BROTH 5ML
EDGE BIOLOGICALS, INC.
T0781
Not in Commercial Distribution

  • B645T07811 ()
  • B645T0781 ()


  • Differential/selective broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0763

SALT BROTH W/ BPC 2ML
EDGE BIOLOGICALS, INC.
T0763
Not in Commercial Distribution

  • B645T07631 ()
  • B645T0763 ()


  • Differential/selective broth culture medium IVD
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