CHAIN DRUG MARKETING ASSOCIATION, 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

Thermometer, Electronic, Clinical (FLL) (4) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (3) Pad, Menstrual, Unscented (HHD) (2) Tampon, Menstrual, Unscented (HEB) (1)

Premarket Exempt

No Yes

Clear

Quality Choice One Step Pregnancy Test - 00635515900486 Catalog Number :

Device Description : FPPL Quality Choice SPS +/-

Device Class :

Duns Number: 011920774

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Quality Choice One Step Pregnancy Test - 00635515900493 Catalog Number :

Device Description : FPPL Quality Choice DPS +/-

Device Class :

Duns Number: 011920774

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Quality Choice - 00635515900936 Catalog Number :

Device Class :

Duns Number: 011920774

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 18

Quality Choice - 00635515901711 Catalog Number :

Device Class :

Duns Number: 011920774

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 24

QUALITY CHOICE - 00635515947443 Catalog Number : QC-94744

Device Description : Quality Choice 60 Second Digital Thermometer

Device Class :

Duns Number: 011920774

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

QUALITY CHOICE - 00635515951471 Catalog Number : QC-95147

Device Description : Quality Choice Deluxe Probe Covers

Device Class : 2

Duns Number: 011920774

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

QUALITY CHOICE - 00635515952249 Catalog Number : QC-95224

Device Description : Quality Choice 2 Second Flexible Tip Digital Thermometer

Device Class :

Duns Number: 011920774

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Quality Choice Early Result Pregnancy Test - 00635515956643 Catalog Number :

Device Description : PLPL Quality Choice SPS Early Result

Device Class : 2

Duns Number: 011920774

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

QUALITY CHOICE - 00635515956971 Catalog Number : QC-95697

Device Description : Quality Choice Temple Touch Mini Thermometer

Device Class : 2

Duns Number: 011920774

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Quality choice Tampons - 00635515958838 Catalog Number :

Device Class :

Duns Number: 011920774

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 20

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