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 e1, Cat dander - 07333066001166 Catalog Number : 14-4109-01

Device Description : ImmunoCAP Allergen e1, Cat dander

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen e5, Dog dander - 07333066001173 Catalog Number : 14-4110-01

Device Description : ImmunoCAP Allergen e5, Dog dander

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen f1, Egg white - 07333066001180 Catalog Number : 14-4111-01

Device Description : ImmunoCAP Allergen f1, Egg white

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen f2, Milk - 07333066001197 Catalog Number : 14-4112-01

Device Description : ImmunoCAP Allergen f2, Milk

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen f4, Wheat - 07333066001203 Catalog Number : 14-4113-01

Device Description : ImmunoCAP Allergen f4, Wheat

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen f14, Soybean - 07333066001210 Catalog Number : 14-4115-01

Device Description : ImmunoCAP Allergen f14, Soybean

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen h1, House dust (Greer Labs. Inc.) - 07333066001227 Catalog Number : 14-4116-01

Device Description : ImmunoCAP Allergen h1, House dust (Greer Labs. Inc.)

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen g3, Cocksfoot - 07333066001234 Catalog Number : 14-4117-01

Device Description : ImmunoCAP Allergen g3, Cocksfoot

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen t17, Japanese cedar - 07333066001241 Catalog Number : 14-4118-01

Device Description : ImmunoCAP Allergen t17, Japanese cedar

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Allergen m3, Aspergillus fumigatus - 07333066001258 Catalog Number : 14-4119-01

Device Description : ImmunoCAP Allergen m3, Aspergillus fumigatus

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

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