HELENA LABORATORIES CORPORATION

Address:1530 Lindbergh Dr,BEAUMONT,TX,77707,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) (CFF) (7) IGD, ANTIGEN, ANTISERUM, CONTROL (CZJ) (2) IGM, ANTIGEN, ANTISERUM, CONTROL (DFT) (1)

Premarket Exempt

No Yes

Clear

Antiserum to Human IgM - M52592340 Catalog Number :

Device Class : 2

Duns Number: 079396131

Premarket Exempt : Yes

Product Code : CFF

Prescription Use : Yes

Device Count : 1

Antiserum to Human Immunoglobulins Trivalent (G, A, M) - M52592360 Catalog Number :

Device Class : 2

Duns Number: 079396131

Premarket Exempt : Yes

Product Code : CFF

Prescription Use : Yes

Device Count : 1

Antiserum to Human IgD - M52592490 Catalog Number :

Device Class : 2

Duns Number: 079396131

Premarket Exempt : Yes

Product Code : CFF

Prescription Use : Yes

Device Count : 1

Antiserum to Human IgE - M52592500 Catalog Number :

Device Class : 2

Duns Number: 079396131

Premarket Exempt : Yes

Product Code : CFF

Prescription Use : Yes

Device Count : 1

Antisera to Human Immunoglobulins Pentavalent (G, A, M, D, E) - M52592510 Catalog Number :

Device Class : 2

Duns Number: 079396131

Premarket Exempt : Yes

Product Code : CFF

Prescription Use : Yes

Device Count : 1

Antiserum to Human Lambda Light Chain - M52592570 Catalog Number :

Device Class : 2

Duns Number: 079396131

Premarket Exempt : Yes

Product Code : CFF

Prescription Use : Yes

Device Count : 1

Antiserum to Human Kappa Light Chain - M52592620 Catalog Number :

Device Class : 2

Duns Number: 079396131

Premarket Exempt : Yes

Product Code : CFF

Prescription Use : Yes

Device Count : 1

ImmunoFix Controls - M52594000 Catalog Number :

Device Class : 2

Duns Number: 079396131

Premarket Exempt : No

Product Code : DFT

Prescription Use : Yes

Device Count : 1

IFE IgD Antiserum - M52594090 Catalog Number :

Device Class : 2

Duns Number: 079396131

Premarket Exempt : No

Product Code : CZJ

Prescription Use : Yes

Device Count : 1

IFE IgE Antiserum - M52594100 Catalog Number :

Device Class : 2

Duns Number: 079396131

Premarket Exempt : No

Product Code : CZJ

Prescription Use : Yes

Device Count : 1

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