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The Stanbio STAT-Site® MHgb Test Kit is intended for the quantitative determination of hemoglobin in whole blood using the Stanbio STAT-Site® MHgb Meter. The STAT-Site® MHgb Test may be used with adults, infants, and children in a physician’s office or other professional point-of-care setting.
STANBIO LABORATORY, L.P.
901025
Not in Commercial Distribution
- 00657498000151 ()
- 00657498001820 ()
901025
- Haemoglobin analyser IVD, point-of-care
The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI).
NANOSPHERE, INC.
20-009-018
Not in Commercial Distribution
- 00857573006218 ()
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
Tri-stat 2 Analyzer
PRIMUS CORPORATION
Tri-stat 2 Analyzer
In Commercial Distribution
- 05391516749473 ()
03-06-0002
- Glycated haemoglobin (HbA1C) analyser IVD
Hemoglobin A1c assay, PDQ Wash Reagent
PRIMUS CORPORATION
PDQ Wash Reagent
In Commercial Distribution
- 05391516748636 ()
- Total Volume: 940 Milliliter
01-03-0067
- Glycated haemoglobin (HbA1c) IVD, reagent
Hemoglobin A1c assay, PDQ Diluent Reagent - 940mL
PRIMUS CORPORATION
PDQ Diluent Reagent - 940mL
In Commercial Distribution
- 05391516748629 ()
- Total Volume: 940 Milliliter
01-03-0066
- Glycated haemoglobin (HbA1c) IVD, reagent
Hemoglobin A1c assay, PDQ 2 Reagent - 940mL
PRIMUS CORPORATION
PDQ 2 Reagent - 940mL
In Commercial Distribution
- 05391516748612 ()
- Total Volume: 940 Milliliter
01-03-0065
- Glycated haemoglobin (HbA1c) IVD, reagent
Hemoglobin A1c assay, PDQ1 Reagent - 940mL
PRIMUS CORPORATION
PDQ1 Reagent - 940mL
In Commercial Distribution
- 05391516748605 ()
- Total Volume: 940 Milliliter
01-03-0064
- Glycated haemoglobin (HbA1c) IVD, reagent
Hemoglobin variants assay, Genesys Diluent Reagent - 3.8L
PRIMUS CORPORATION
Genesys Diluent Reagent - 3.8L
In Commercial Distribution
- 05391516748193 ()
- Total Volume: 3.8 Liter
01-03-0019
- Multiple haemoglobin subtype IVD, reagent
Hemoglobin variants assay, Ultra2 Resolution 500 kit
PRIMUS CORPORATION
Ultra2 Resolution 500
In Commercial Distribution
- 05391516748186 ()
01-04-0078
- Inherited haemoglobinopathy IVD, reagent
Hemoglobin A1c assay, Ultra2 Affinity A1c 3000
PRIMUS CORPORATION
Ultra2 Affinity A1c 3000
In Commercial Distribution
- 05391516748162 ()
01-04-0080
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography