Monobind AccuLite C-Peptide CLIA Kit - 96 Wells 2775-300A

GUDID 00816870022413

MONOBIND, INC.

C-peptide IVD, kit, chemiluminescent immunoassay
Primary Device ID00816870022413
NIH Device Record Key7d472f44-4c74-457b-bdea-b32449cc5b5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind AccuLite C-Peptide CLIA Kit - 96 Wells
Version Model Number2775-300
Catalog Number2775-300A
Company DUNS083155515
Company NameMONOBIND, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(949)951-2665
Emailinfo@monobind.com

Device Dimensions

Width7.75 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816870022413 [Primary]

FDA Product Code

JKDRADIOIMMUNOASSAY, C-PEPTIDES OF PROINSULIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-11

Devices Manufactured by MONOBIND, INC.

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00816870020624 - Monobind AccuBind PSA ELISA Kit - 192 Wells2020-02-06
00816870020631 - Monobind AccuBind PSA Extra Sensitive ELISA Kit - 96 Wells2020-02-06
00816870020648 - Monobind AccuBind PSA Extra Sensitive ELISA Kit - 192 Wells2020-02-06
00816870022277 - Monobind AccuLite Free PSA CLIA Kit - 96 Wells2020-02-06
00816870022284 - Monobind AccuLite Free PSA CLIA Kit - 192 Wells2020-02-06

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