PTH (Parathyroid) Intact ELISA EIA-3645

GUDID 00840239036452

The PTH (Parathyroid) Intact ELISA is intended for the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum.

DRG International Inc

Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	00840239036452
NIH Device Record Key	2435202b-41f2-46f7-a306-efb9f66196a4
Commercial Distribution Status	In Commercial Distribution
Brand Name	PTH (Parathyroid) Intact ELISA
Version Model Number	EIA-3645
Catalog Number	EIA-3645
Company DUNS	075150847
Company Name	DRG International Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com

Device Dimensions

Total Volume	20 Milliliter
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Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
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Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
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Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
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Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
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Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	7 Milliliter
Total Volume	2 Milliliter
Total Volume	5 Milliliter
Total Volume	30 Milliliter
Total Volume	0.5 Milliliter
Total Volume	20 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239036452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K974306

FDA Product Code

CEW	RADIOIMMUNOASSAY, PARATHYROID HORMONE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2020-03-30
Device Publish Date	2019-03-20

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