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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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Thyretain - 30014613331612

TSI POSITIVE SERUM
DIAGNOSTIC HYBRIDS, INC.
40-520050.V2
In Commercial Distribution

  • 30014613331612 ()
40-520050.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

Thyretain - 30014613331599

THYRETAIN CELL ATTACH SOLUT
DIAGNOSTIC HYBRIDS, INC.
40-400200.V2
In Commercial Distribution

  • 30014613331599 ()
40-400200.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

Thyretain - 30014613331568

THYRETAIN REACTION BUFFER
DIAGNOSTIC HYBRIDS, INC.
40-300500.V2
In Commercial Distribution

  • 30014613331568 ()
40-300500.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

Thyretain - 30014613331513

THYRETAIN CELL AND Control SET
DIAGNOSTIC HYBRIDS, INC.
40-1050.V2
In Commercial Distribution

  • 30014613331513 ()
40-1050.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

ELVIS - 30014613330202

ELVIS SOL 3, 12ML
DIAGNOSTIC HYBRIDS, INC.
00-013012.V2
In Commercial Distribution

  • 30014613330202 ()
00-013012.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

ELVIS - 30014613330196

ELVIS SOL 3, 3ML
DIAGNOSTIC HYBRIDS, INC.
00-013003.V2
In Commercial Distribution

  • 30014613330196 ()
00-013003.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

D3 - 30014613338680

hMPV Antigen Control Slides
DIAGNOSTIC HYBRIDS, INC.
01-00070.v2
In Commercial Distribution

  • 30014613338680 ()
01-00070.v2

  • Human metapneumovirus (hMPV) antigen IVD, control

ELVIS - 30014613336020

INTL-ONLY ELVIS TYPE KIT 60-TE
DIAGNOSTIC HYBRIDS, INC.
I-SKT-ELVIS-60.V2
In Commercial Distribution

  • 30014613336020 ()
I-SKT-ELVIS-60.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

DHI Specimen Collection System - 30014613335443

KIT, MALE WITH UTM
DIAGNOSTIC HYBRIDS, INC.
99-08012.V2
In Commercial Distribution

  • 30014613335443 ()
99-08012.V2

  • General specimen collection kit IVD, clinical

DHI Specimen Collection System - 30014613335436

KIT, FEMALE WITH UTM
DIAGNOSTIC HYBRIDS, INC.
99-08011.V2
In Commercial Distribution

  • 30014613335436 ()
99-08011.V2

  • General specimen collection kit IVD, clinical

Thyretain - 30014613331544

THYR LUCIFERASE REAGENT SET
DIAGNOSTIC HYBRIDS, INC.
40-3000.V2
In Commercial Distribution

  • 30014613331544 ()
40-3000.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

Thyretain - 30014613331520

THYRETAIN MEDIA SET
DIAGNOSTIC HYBRIDS, INC.
40-2000.V2
In Commercial Distribution

  • 30014613331520 ()
40-2000.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

Thyretain - 30014613331506

THYRETAIN CELLS AND Control SET
DIAGNOSTIC HYBRIDS, INC.
40-1025.V2
In Commercial Distribution

  • 30014613331506 ()
40-1025.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

Thyretain - 30014613331483

THYRETAIN GROWTH MEDIUM
DIAGNOSTIC HYBRIDS, INC.
40-100200.V2
In Commercial Distribution

  • 30014613331483 ()
40-100200.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

D3 Ultra - 30014613330479

Parainfluenza 3 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013702.V2
In Commercial Distribution

  • 30014613330479 ()
01-013702.V2

  • Human parainfluenza virus 3 antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330462

Parainfluenza 2 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013602.V2
In Commercial Distribution

  • 30014613330462 ()
01-013602.V2

  • Human parainfluenza virus 2 antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330455

Parainfluenza 1 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013502.V2
In Commercial Distribution

  • 30014613330455 ()
01-013502.V2

  • Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330431

Adeno DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013402.V2
In Commercial Distribution

  • 30014613330431 ()
01-013402.V2

  • Adenovirus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330424

RSV DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013302.V2
In Commercial Distribution

  • 30014613330424 ()
01-013302.V2

  • Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330417

Influenza B DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013202.V2
In Commercial Distribution

  • 30014613330417 ()
01-013202.V2

  • Influenza B virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330394

Influenza A DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013102.V2
In Commercial Distribution

  • 30014613330394 ()
01-013102.V2

  • Influenza A virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330370

DFA Respiratory Virus Screening Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013010.V2
In Commercial Distribution

  • 30014613330370 ()
01-013010.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330356

D3 Ultra DFA Respiratory Virus ID Set
DIAGNOSTIC HYBRIDS, INC.
01-010007.V2
In Commercial Distribution

  • 30014613330356 ()
01-010007.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330349

D3 Ultra DFA Parainfluenza Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010006.V2
In Commercial Distribution

  • 30014613330349 ()
01-010006.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330325

De Ultra DFA Influenza A/Influenza B Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010004.V2
In Commercial Distribution

  • 30014613330325 ()
01-010004.V2

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330318

D3 Ultra DFA RSV Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010003.V2
In Commercial Distribution

  • 30014613330318 ()
01-010003.V2

  • Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330301

D3 Ultra DFA Respiratory Virus Shell Vial Screening Set
DIAGNOSTIC HYBRIDS, INC.
01-010002.V2
In Commercial Distribution

  • 30014613330301 ()
01-010002.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330295

D3 Ultra DFA Respiratory Virus Direct Specimen Screening set
DIAGNOSTIC HYBRIDS, INC.
01-010001.V2
In Commercial Distribution

  • 30014613330295 ()
01-010001.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330288

D3 Ultra DFA Respiratory Virus Screening and ID kit
DIAGNOSTIC HYBRIDS, INC.
01-010000.V2
In Commercial Distribution

  • 30014613330288 ()
01-010000.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

De Mayo V2®/V2E® Knee Positioner® - 00696588005393

Evaluation De Mayo V2®/V2E® Knee Positioner® Clamp
Innovative Medical Products, Inc
114-CL EVAL
In Commercial Distribution

  • 00696588005393 ()
114-CL EVAL

  • Medical table clamp
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