ALFA SCIENTIFIC DESIGNS, INC.

Address:13200 GREGG ST.,POWAY,CA,92064,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

Enzyme Immunoassay, Opiates (DJG) (5) Radioimmunoassay, Follicle-Stimulating Hormone (CGJ) (2) Radioimmunoassay, Luteinizing Hormone (CEP) (2) Enzyme Immunoassay, Propoxyphene (JXN) (1)

Premarket Exempt

Clear

INSTANT-VIEW LH Ovulation Predicting Cassette Test - 10796918000115 Catalog Number :

Device Description : INSTANT-VIEW LH Ovulation Predicting Cassette Test

Device Class :

Duns Number: 176391167

Premarket Exempt : No

Product Code : CEP

Prescription Use : No

Device Count : 25

INSTANT-VIEW LH Ovulation Predicting Dip-Strip Test - 10796918000122 Catalog Number :

Device Description : INSTANT-VIEW LH Ovulation Predicting Dip-Strip Test

Device Class :

Duns Number: 176391167

Premarket Exempt : No

Product Code : CEP

Prescription Use : No

Device Count : 50

INSTANT-VIEW FSH Cassette Test - 10796918000139 Catalog Number :

Device Description : INSTANT-VIEW FSH Cassette Test

Device Class :

Duns Number: 176391167

Premarket Exempt : No

Product Code : CGJ

Prescription Use : No

Device Count : 25

INSTANT-VIEW FSH Dip-Strip Test - 10796918000146 Catalog Number :

Device Description : INSTANT-VIEW FSH Dip-Strip Test

Device Class :

Duns Number: 176391167

Premarket Exempt : No

Product Code : CGJ

Prescription Use : No

Device Count : 50

INSTANT-VIEW Buprenorphine/ Norbuprenorphine Urine Cassette Test - 10796918000153 Catalog Number :

Device Description : INSTANT-VIEW Buprenorphine/ Norbuprenorphine Urine Cassette Test, BUP

Device Class :

Duns Number: 176391167

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 25

INSTANT-VIEW Buprenorphine/ Norbuprenorphine Urine Dip-Strip Test - 10796918000160 Catalog Number :

Device Description : INSTANT-VIEW Buprenorphine/ Norbuprenorphine Urine Dip-Strip Test

Device Class :

Duns Number: 176391167

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 50

INSTANT-VIEW Oxycodone (100) Urine Cassette Test - 10796918000177 Catalog Number :

Device Description : INSTANT-VIEW Oxycodone (100) Urine Cassette Test

Device Class :

Duns Number: 176391167

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 25

INSTANT-VIEW OXY100 Urine Dip Cassette Test - 10796918000184 Catalog Number :

Device Description : INSTANT-VIEW OXY100 Urine Dip Cassette Test

Device Class :

Duns Number: 176391167

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 25

INSTANT-VIEW OXY300 Urine Dip Cassette Test - 10796918000191 Catalog Number :

Device Description : INSTANT-VIEW OXY300 Urine Dip Cassette Test

Device Class :

Duns Number: 176391167

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 25

INSTANT-VIEW Propoxyphene (PPX) Urine Cassette Test - 10796918000207 Catalog Number :

Device Description : INSTANT-VIEW Propoxyphene (PPX) Urine Cassette Test

Device Class :

Duns Number: 176391167

Premarket Exempt : No

Product Code : JXN

Prescription Use : No

Device Count : 25

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