Phadia AB

Address:RAPSGATAN 7P,UPPSALA,SE

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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

SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL (DHB) (10)

Premarket Exempt

No Yes

Clear

ImmunoCAP Allergen m5, Candida albicans - 07333066001265 Catalog Number : 14-4120-01

Device Description : ImmunoCAP Allergen m5, Candida albicans

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen e3, Horse dander - 07333066001272 Catalog Number : 14-4122-01

Device Description : ImmunoCAP Allergen e3, Horse dander

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen f5, Rye - 07333066001289 Catalog Number : 14-4123-01

Device Description : ImmunoCAP Allergen f5, Rye

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen f8, Maize, Corn - 07333066001296 Catalog Number : 14-4124-01

Device Description : ImmunoCAP Allergen f8, Maize, Corn

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen f11, Buckwheat - 07333066001302 Catalog Number : 14-4125-01

Device Description : ImmunoCAP Allergen f11, Buckwheat

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen f13, Peanut - 07333066001319 Catalog Number : 14-4126-01

Device Description : ImmunoCAP Allergen f13, Peanut

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen f33, Orange - 07333066001333 Catalog Number : 14-4129-01

Device Description : ImmunoCAP Allergen f33, Orange

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen g1, Sweet vernal grass - 07333066001340 Catalog Number : 14-4130-01

Device Description : ImmunoCAP Allergen g1, Sweet vernal grass

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen g2, Bermuda grass - 07333066001357 Catalog Number : 14-4131-01

Device Description : ImmunoCAP Allergen g2, Bermuda grass

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen g4, Meadow fescue - 07333066001364 Catalog Number : 14-4133-01

Device Description : ImmunoCAP Allergen g4, Meadow fescue

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

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