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Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
MJX
Kit, Serological, Positive Control
1
Product Code
K
10
1434
AUDIT MICROCV PROCALCITONIN LINEARITY
1
Cleared 510(K)
K
03
0067
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
1
Cleared 510(K)
K
97
4262
SYSCOS IDC - G, IDC, BSC, IDC - G
1
Cleared 510(K)
K
97
2986
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
1
Cleared 510(K)
K
97
0100
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
1
Cleared 510(K)
K
93
4137
OPUS(R) SEROLOGY CONTROLS, MODIFICATION
1
Cleared 510(K)
K
92
5703
OPUS SEROLOGY CONTROLS
1
Cleared 510(K)
MJY
Kit, Serological, Negative Control
1
Product Code
MJZ
Kit, Direct Antigen, Positive Control
1
Product Code
MKA
Kit, Direct Antigen, Negative Control
1
Product Code
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart C—Microbiology Devices
CFR Sub-Part
Subpart D—Serological Reagents
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Last synced on 25 January 2026 at 3:41 am
MI
/
subpart-b—clinical-chemistry-test-systems
/
MJX
/
K972986
View Source
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
Loading...
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Miscellaneous
Subpart B—Biological Stains
Subpart B—Clinical Chemistry Test Systems
MJX
Kit, Serological, Positive Control
K
10
1434
AUDIT MICROCV PROCALCITONIN LINEARITY
K
03
0067
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K
97
4262
SYSCOS IDC - G, IDC, BSC, IDC - G
K
97
2986
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
K
97
0100
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
K
93
4137
OPUS(R) SEROLOGY CONTROLS, MODIFICATION
K
92
5703
OPUS SEROLOGY CONTROLS
MJY
Kit, Serological, Negative Control
MJZ
Kit, Direct Antigen, Positive Control
MKA
Kit, Direct Antigen, Negative Control
Subpart B—Diagnostic Devices
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
Subpart D—Serological Reagents
Subpart F—Immunological Test Systems
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
MI
/
subpart-b—clinical-chemistry-test-systems
/
MJX
/
K972986
View Source
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
Loading...