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Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3923
Not in Commercial Distribution
- 00840487100219 ()
3923
- Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3922
Not in Commercial Distribution
- 00840487100202 ()
3922
- Multiple Fusobacterium species nucleic acid IVD, reagent
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3921
Not in Commercial Distribution
- 00840487100196 ()
3921
- Multiple Bordetella species nucleic acid IVD, reagent
Epi proColon Control Kit
Epigenomics AG
Control Kit
In Commercial Distribution
- 04260400670029 ()
M5-02-003
- Methylated DNA IVD, kit, nucleic acid technique (NAT)
Epi proColon Sensitive PCR Kit
Epigenomics AG
Sensitive PCR Kit
In Commercial Distribution
- 04260400670012 ()
M5-02-002
- Methylated DNA IVD, kit, nucleic acid technique (NAT)
Buffer based solution with containing non-pathogenic bacterial strains with the T2Biothreat Panel target sequences.
T2 BIOSYSTEMS, INC.
85-11396
In Commercial Distribution
- M70883113950 ()
- M70885113963 ()
- Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
Positive ASK Control, Positive EPE Control
T2 BIOSYSTEMS, INC.
85-08073
In Commercial Distribution
- M70885080730 ()
- Total Volume: 4 Milliliter
- Multiple bloodstream bacteria nucleic acid IVD, control
The Stratus® CS Acute Care™ Troponin I Calibrator (cTNI CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care™ cTNI method.
Siemens Healthcare Diagnostics Inc.
10445072
In Commercial Distribution
- 00842768004537 ()
- 00630414009865 ()
CCTNI-CR
- Troponin I IVD, kit, fluorescent immunoassay
Negative quality control for T2Biothreat Panel
T2 BIOSYSTEMS, INC.
85-11398
In Commercial Distribution
- M70883113970 ()
- M70885113983 ()
- Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
Negative Control
T2 BIOSYSTEMS, INC.
85-08376
In Commercial Distribution
- M70885083763 ()
- M70885083760 ()
- M70883083580 ()
- Total Volume: 4 Milliliter
- Multiple Candida species nucleic acid IVD, control