IMMUNODIAGNOSTIC SYSTEMS LIMITED

Address:10 DIDCOT WAY,BOLDON, TYNE & WEAR Northumberland,GB

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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

Column Chromatography & Color Development, Hydroxyproline (JMM) (5) System, Test, Vitamin D (MRG) (4) Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (CIN) (1)

Premarket Exempt

No Yes

Clear

25-Hydroxy Vitamin D RIA - 05060169690004 Catalog Number :

Device Class : 2

Duns Number: 494268600

Premarket Exempt : No

Product Code : MRG

Prescription Use : Yes

Device Count : 1

1,25 Dihydroxy Vitamin D RIA - 05060169690011 Catalog Number :

Device Class : 2

Duns Number: 494268600

Premarket Exempt : No

Product Code : MRG

Prescription Use : Yes

Device Count : 1

1,25 Dihydroxy Vitamin D RIA - 05060169690028 Catalog Number :

Device Class : 2

Duns Number: 494268600

Premarket Exempt : No

Product Code : MRG

Prescription Use : Yes

Device Count : 1

Ostase®+ BAP EIA - 05060169690059 Catalog Number :

Device Class : 2

Duns Number: 494268600

Premarket Exempt : No

Product Code : CIN

Prescription Use : Yes

Device Count : 1

1,25-Dihydroxy Vitamin D EIA - 05060169690097 Catalog Number :

Device Class : 2

Duns Number: 494268600

Premarket Exempt : No

Product Code : MRG

Prescription Use : Yes

Device Count : 1

Serum CrossLaps® (CTX-I) ELISA - 05060169690134 Catalog Number :

Device Class : 1

Duns Number: 494268600

Premarket Exempt : No

Product Code : JMM

Prescription Use : Yes

Device Count : 1

Urine BETA CrossLaps® (CTX-I) ELISA - 05060169690158 Catalog Number :

Device Class : 1

Duns Number: 494268600

Premarket Exempt : Yes

Product Code : JMM

Prescription Use : Yes

Device Count : 1

Alpha CrossLaps® (CTX-I) EIA - 05060169690165 Catalog Number :

Device Class : 1

Duns Number: 494268600

Premarket Exempt : Yes

Product Code : JMM

Prescription Use : Yes

Device Count : 1

Urine CartiLaps ® (CTX-II) EIA - 05060169690172 Catalog Number :

Device Class : 1

Duns Number: 494268600

Premarket Exempt : Yes

Product Code : JMM

Prescription Use : Yes

Device Count : 1

IDS-iSYS CTX-I (Crosslaps) - 05060169690240 Catalog Number :

Device Class : 1

Duns Number: 494268600

Premarket Exempt : Yes

Product Code : JMM

Prescription Use : Yes

Device Count : 1

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