INSTRUMENTATION LABORATORY COMPANY

Address:526 Route 303,ORANGEBURG,NY,10962,US

Want to know more about this Organization? Request more information now!

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

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (7) Electrode, Ion Specific, Sodium (JGS) (1) PLATELET FACTOR 4 RADIOIMMUNOASSAY (LCO) (1) Plasma, coagulation control (GGN) (1)

Premarket Exempt

No Yes

Clear

GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct - 08426951070848 Catalog Number : 00044345008

Device Description : GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 450 test PAK

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : JGS

Prescription Use : Yes

Device Count : 1

HemosIL Acustar HIT Controls - 08426951126538 Catalog Number : 00009800131

Device Description : 1. Low HIT Control (Cat. No. 00009800132)2. High HIT Control (Cat. No. 00009800133):

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGN

Prescription Use : Yes

Device Count : 6

HemosIL AcuStar HIT-IgG (PF4-H) - 08426951126545 Catalog Number : 00009800127

Device Description : 1. HIT- IgG(PF4-H)Cartridges for 25 determinations (Cat No 0009800128) 2. HIT-I 1. HIT- IgG(PF4-H)Cartridges for 25 determinations (Cat No 0009800128) 2. HIT-IgG (PF4-H) Calibaratior 1 (Cat No 0009800129)3. HIT-IgG (PF4-H) Calibaratior 2 (Cat No 0009800130)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : LCO

Prescription Use : Yes

Device Count : 1

GEM ChemSTAT CVP 1 - 08426951293742 Catalog Number : 00044000115

Device Description : GEM ChemSTAT CVP 1, 10 ampoules x 1.8 mL

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 10

GEM ChemSTAT CVP 2 - 08426951293759 Catalog Number : 00044000125

Device Description : GEM ChemSTAT CVP 2, 10 ampoules x 1.8 mL

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 10

GEM ChemSTAT CVP 3 - 08426951293766 Catalog Number : 00044000130

Device Description : GEM ChemSTAT CVP 3, 10 ampoules x 1.8 mL

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 10

GEM ChemSTAT CVP 4 - 08426951293773 Catalog Number : 00044000140

Device Description : GEM ChemSTAT CVP 4, 10 ampoules x 1.8 mL

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 10

GEM ChemSTAT PVP 1-5 - 08426951293780 Catalog Number : 00044001515

Device Description : GEM ChemSTAT PVP1-5, 5 levels x 5 ampoules x 1.8 mL

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 5

ChemSTAT System Evaluator 1 - 08426951293797 Catalog Number : 00044000101

Device Description : ChemSTAT System Evaluator 1, 10 ampoules x 1.8 mL

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 10

ChemSTAT System Evaluator 2 - 08426951293803 Catalog Number : 00044000102

Device Description : ChemSTAT System Evaluator 2, 10 ampoules x 1.8 mL

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 10

Previous 1 … 37 38 39 40 41 Next