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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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IgE, RPab - B502BSB30700

IgE is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB30700 ()
BSB 3070

  • Total immunoglobulin E (IgE total) IVD, antibody

Tinto IgE, RPab - B502BSB30690

IgE is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB30690 ()
BSB 3069

  • Total immunoglobulin E (IgE total) IVD, antibody

Tinto IgE, RPab - B502BSB30680

IgE is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB30680 ()
BSB 3068

  • Total immunoglobulin E (IgE total) IVD, antibody

Tinto IgE, RPab - B502BSB30670

IgE is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 1 ml
In Commercial Distribution

  • B502BSB30670 ()
BSB 3067

  • Total immunoglobulin E (IgE total) IVD, antibody

IgE / FITC control slides - B502BSB3011CS0

IgE / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3011CS0 ()
BSB 3011-CS

  • Total immunoglobulin E (IgE total) IVD, control

Tinto IgE / FITC GPab - B502BSB301170

Tinto IgE/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris-Buffered Saline solution (pH 7.2).
BIO SB, INC.
predilute, 7 ml.
In Commercial Distribution

  • B502BSB301170 ()
BSB 3011-7

  • Total immunoglobulin E (IgE total) IVD, antibody

Tinto IgE / FITC GPab - B502BSB301130

Tinto IgE/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris-Buffered Saline solution (pH 7.2).
BIO SB, INC.
predilute, 3 ml.
In Commercial Distribution

  • B502BSB301130 ()
BSB 3011-3

  • Total immunoglobulin E (IgE total) IVD, antibody

Tinto IgE / FITC GPab - B502BSB3011150

Tinto IgE/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris-Buffered Saline solution (pH 7.2)
BIO SB, INC.
predilute, 15 ml.
In Commercial Distribution

  • B502BSB3011150 ()
BSB 3011-15

  • Total immunoglobulin E (IgE total) IVD, antibody

IgE / FITC GPab - B502BSB30111

The IgE/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2)
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB30111 ()
BSB 3011-1

  • Total immunoglobulin E (IgE total) IVD, antibody

IgE / FITC GPab - B502BSB3011050

IgE/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tri-sBuffered Saline solution (pH 7.2).
BIO SB, INC.
concentrate, 0.5 ml.
In Commercial Distribution

  • B502BSB3011050 ()
BSB 3011-05

  • Total immunoglobulin E (IgE total) IVD, antibody

Total Immunoglobulin E (IgE) - 15099590701727

Total Immunoglobulin E (IgE) Reagent kit for AU/DxC AU clinical chemistry analyzers.
Beckman Coulter, Inc.
C22529
In Commercial Distribution

  • 15099590701727 ()


  • Total immunoglobulin E (IgE total) IVD, antibody

IMMAGE - 15099590227029

IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent
Beckman Coulter, Inc.
474620
In Commercial Distribution

  • 15099590227029 ()
474620

  • Total immunoglobulin E (IgE total) IVD, antibody

ADVIA Centaur® tIgE - 00630414177489

IgE - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10309986
In Commercial Distribution

  • 00630414177489 ()
  • 00630414003269 ()
110778

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® tIgE - 00630414177472

IgE - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309985
In Commercial Distribution

  • 00630414177472 ()
110777

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

Atellica IM tIgE - 00630414599380

IgE (tIgE) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995615
In Commercial Distribution

  • 00630414599380 ()
10995615

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

Atellica IM tIgE - 00630414599373

IgE (tIgE) Atellica IM – RGT 250T
Siemens Healthcare Diagnostics Inc.
10995614
In Commercial Distribution

  • 00630414599373 ()
  • 00630414007601 ()
10995614

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

GC Plastic Syringe - 10386040006309

GC Plastic Syringe Tips Package of 10
Gc America Inc.
159310
In Commercial Distribution

  • 00386040006302 ()
  • 10386040006309 ()
159310

  • Haemoglobin E (HbE) IVD, calibrator

GC Plastic Syringe - 10386040006286

GC Plastic Syringe Tips, Package of 100
Gc America Inc.
159300
In Commercial Distribution

  • 00386040006289 ()
  • 10386040006286 ()
159300

  • Haemoglobin E (HbE) IVD, calibrator

GC Plastic Syringe - 10386040004121

Plastic Syringe Tips, Type A, Box of 25
Gc America Inc.
159225
In Commercial Distribution

  • 00386040004124 ()
  • 10386040004121 ()
159225

  • Haemoglobin E (HbE) IVD, calibrator

IgE AccuLite CLIA Test System - 960 Wells - 00816870021959

No Description
MONOBIND, INC.
2575-300
In Commercial Distribution

  • 00816870021959 ()

  • Width: 12 Inch
2575-300E

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

IgE AccuLite CLIA Test System - 480 Wells - 00816870021942

No Description
MONOBIND, INC.
2575-300
In Commercial Distribution

  • 00816870021942 ()

  • Width: 12 Inch
2575-300D

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

Monobind AccuLite IgE CLIA Kit - 96 Wells - 00816870021928

No Description
MONOBIND, INC.
2575-300
In Commercial Distribution

  • 00816870021928 ()

  • Width: 7.75 Inch
2575-300A

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

IgE AccuLite CLIA Test System - 192 Wells - 00816870021935

No Description
MONOBIND, INC.
2575-300
In Commercial Distribution

  • 00816870021935 ()

  • Width: 7.75 Inch
2575-300B

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

InTray® SMA - B08814230

a selective and differential media for the detection of sorbitol-non-fermenting Escherichia coli serotype O157:H7 associated with hemorrhagic colitis. This medium is also referred to as "MacConkey Sorbitol Agar."
BIO-MED DIAGNOSTICS, INC.
1423
In Commercial Distribution

  • B08814234 ()
  • B08814230 ()
  • B08814232 ()
21-423-001

  • Sorbitol-MacConkey E. coli agar culture medium IVD

Solid Abutment - 08800039305754

No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
HISS5544
In Commercial Distribution

  • 08800039305754 ()


  • Haemoglobin E (HbE) IVD, calibrator

GC Plastic Syringe - D6581593101

GC Plastic Syringe Tips Package of 10
Gc America Inc.
159310
In Commercial Distribution

  • D6581593101 ()
  • D6581593100 ()
159310

  • Haemoglobin E (HbE) IVD, calibrator

GC Plastic Syringe - D6581593001

GC Plastic Syringe Tips, Package of 100
Gc America Inc.
159300
In Commercial Distribution

  • D6581593001 ()
  • D6581593000 ()
159300

  • Haemoglobin E (HbE) IVD, calibrator

GC Plastic Syringe - D6581592251

Plastic Syringe Tips, Type A, Box of 25
Gc America Inc.
159225
In Commercial Distribution

  • D6581592251 ()
  • D6581592250 ()
159225

  • Haemoglobin E (HbE) IVD, calibrator

Alinity - 00380740153700

IgE Reagent Kit 200 tests
ABBOTT LABORATORIES
01R1321
In Commercial Distribution

  • 00380740153700 ()
01R1321

  • Total immunoglobulin E (IgE total) IVD, kit, nephelometry/turbidimetry

Access Total IgE - 15099590221324

The Access Total IgE assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative determination of total E (IgE) levels in human serum and plasma (heparin, EDTA) using the Access Immunoassay Systems.
Beckman Coulter, Inc.
35000
Not in Commercial Distribution

  • 15099590221324 ()
35000

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

Access Total IgE Calibrators - 15099590221317

The Access Total IgE Calibrators are intended to calibrate the Access Total IgE assay for the quantitative determination of total IgE levels in human serum and plasma (heparin, EDTA) using the Access Immunoassay Systems.
Beckman Coulter, Inc.
35005
Not in Commercial Distribution

  • 15099590221317 ()
35005

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

Access Total IgE Calibrator S0 - 15099590221300

The Access Total IgE Calibrator S0 is intended for use with the Access Total IgE assay to dilute patient samples containing analyte concentrations greater than the analyte specific S6 calibrator.
Beckman Coulter, Inc.
35006
In Commercial Distribution

  • 15099590221300 ()
35006

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740030100

Quantia IgE Calibrators
ABBOTT LABORATORIES
6K50-02
In Commercial Distribution

  • 00380740030100 ()
06K5002

  • Total immunoglobulin E (IgE total) IVD, calibrator

AIA-PACK IgEII Calibrator Set - 04560189211070

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211070 ()


  • Total immunoglobulin E (IgE total) IVD, calibrator

IgE AccuBind ELISA Test System - 480 Wells - 00816870020266

No Description
MONOBIND, INC.
2525-300
In Commercial Distribution

  • 00816870020266 ()

  • Width: 12 Inch
2525-300D

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

Monobind AccuBind IgE ELISA Kit - 192 Wells - 00816870020259

No Description
MONOBIND, INC.
2525-300
In Commercial Distribution

  • 00816870020259 ()

  • Width: 7.75 Inch
2525-300B

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

IgE AccuBind ELISA Test System - 96 Wells - 00816870020242

No Description
MONOBIND, INC.
2525-300
In Commercial Distribution

  • 00816870020242 ()

  • Width: 7.75 Inch
2525-300A

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

IgE-XR AccuBind ELISA Test System - 96 Wells - 00816870024400

No Description
MONOBIND, INC.
13025-300
In Commercial Distribution

  • 00816870024400 ()

  • Width: 7.75 Inch
13025-300A

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

IgE AccuBind ELISA Test System - 960 Wells - 00816870020273

No Description
MONOBIND, INC.
2525-300
In Commercial Distribution

  • 00816870020273 ()

  • Width: 12 Inch
2525-300E

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

Total IgE ELISA - B24225IGEHUE010

The Total IgE ELISA is intended for use in the quantitative determination of immunoglobulin E in human serum. The assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
25-IGEHU-E01
Not in Commercial Distribution

  • B24225IGEHUE010 ()
25-IGEHU-E01

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

PreciControl Anti-HBe - 04015630938872

Anti-HBe PC Elecsys
Roche Diagnostics GmbH
11876384160
In Commercial Distribution

  • 04015630938872 ()
11876384160

  • Hepatitis E virus total antibody IVD, control

ARCHITECT - 00380740156367

Quantia IgE Calibrators
ABBOTT LABORATORIES
06K5004
In Commercial Distribution

  • 00380740156367 ()
06K5004

  • Total immunoglobulin E (IgE total) IVD, calibrator

Alinity - 00380740153694

IgE Calibrators
ABBOTT LABORATORIES
01R1302
In Commercial Distribution

  • 00380740153694 ()
01R1302

  • Total immunoglobulin E (IgE total) IVD, calibrator

ImmunoCAP Total IgE Anti-IgE - 07333066004037

ImmunoCAP Total IgE Anti-IgE
Phadia AB
14-4509-01
In Commercial Distribution

  • 07333066004037 ()
14-4509-01

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Total IgE Conjugate 400 - 07333066019864

ImmunoCAP Total IgE Conjugate 400
Phadia AB
34-2325-42
In Commercial Distribution

  • 07333066000664 ()
  • 07333066019864 ()
34-2325-42

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Total IgE Calibrator Strip - 07333066019796

ImmunoCAP Total IgE Calibrator Strip
Phadia AB
34-2274-81
In Commercial Distribution

  • 07333066000367 ()
  • 07333066019796 ()
34-2274-81

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Total IgE Curve Control Strip - 07333066019789

ImmunoCAP Total IgE Curve Control Strip
Phadia AB
34-2274-51
In Commercial Distribution

  • 07333066000220 ()
  • 07333066019789 ()
34-2274-51

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Total IgE Conjugate 100 - 07333066019772

ImmunoCAP Total IgE Conjugate 100
Phadia AB
34-2272-22
In Commercial Distribution

  • 07333066000206 ()
  • 07333066019772 ()
34-2272-22

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Total IgE - 07333066019673

Contains one bottle of Total IgE Conjugate and four vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method.
Phadia AB
10-9517-02
In Commercial Distribution

  • 07333066019673 ()
10-9517-02

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Total IgE Curve Controls - 07333066019529

Contains three vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method.
Phadia AB
10-9257-01
In Commercial Distribution

  • 07333066019529 ()
10-9257-01

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
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