POLYMEDCO, INC.

POLYMEDCO, INC.

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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

Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Antigens, Cf (Including Cf Control), Influenza Virus A, B, C (GNX) (2) Antigens, All Groups, Streptococcus Spp. (GTY) (2) Visual, Pregnancy Hcg, Prescription Use (JHI) (1) Helicobacter Pylori (LYR) (1) Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (DHN) (1) System, Test, Infectious Mononucleosis (KTN) (1)

Premarket Exempt

No

Clear

Poly stat - 00816917021546 Catalog Number :

Device Description : Mono, Immunochromatographic

Device Class : 2

Duns Number: 024798555

Premarket Exempt : No

Product Code : KTN

Prescription Use : No

Device Count : 1

Poly stat - 00816917022925 Catalog Number :

Device Description : Flu A & B, Immunochromatographic, 25 Test Kit

Device Class : 1

Duns Number: 024798555

Premarket Exempt : No

Product Code : GNX

Prescription Use : No

Device Count : 1

PolyTiter - 00855574005360 Catalog Number :

Device Description : Anti Nuclear Antibody, Calibrator, PolyTiter

Device Class : 2

Duns Number: 024798555

Premarket Exempt : No

Product Code : DHN

Prescription Use : No

Device Count : 1

Poly stat - 00855574005377 Catalog Number :

Device Description : Qualitative HCG Control

Device Class : 1

Duns Number: 024798555

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Poly stat - 00855574005384 Catalog Number :

Device Description : HCG, Immunochromatographic Test

Device Class : 2

Duns Number: 024798555

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

Poly stat - 00855574005391 Catalog Number :

Device Description : Qualitative HCG Control, Urine

Device Class : 1

Duns Number: 024798555

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Poly stat - 00855574005407 Catalog Number :

Device Description : Flu A & B, Immunochromatographic

Device Class : 1

Duns Number: 024798555

Premarket Exempt : No

Product Code : GNX

Prescription Use : No

Device Count : 1

Poly stat - 00855574005414 Catalog Number :

Device Description : H. Pylori, Immunochromatographic

Device Class : 1

Duns Number: 024798555

Premarket Exempt : No

Product Code : LYR

Prescription Use : No

Device Count : 1

Poly stat - 00855574005421 Catalog Number :

Device Description : Strep A, Immunochromatographic

Device Class : 1

Duns Number: 024798555

Premarket Exempt : No

Product Code : GTY

Prescription Use : No

Device Count : 1

Poly stat - 00855574005438 Catalog Number :

Device Description : Strep A, Immunochromatographic, Flip

Device Class : 1

Duns Number: 024798555

Premarket Exempt : No

Product Code : GTY

Prescription Use : No

Device Count : 1

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